Avant™, Neutrino™ NxT, Gallant™, Entrant™ Cardiac Resynchronization Therapy Defibrillator, Implantable Cardioverter Defibrillator
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. © 2019 Abbott. All Rights Reserved. St.
Device Description This manual describes the following Abbott Medical pulse generators: Table 1. Single-chamber pulse generator descriptions Name Model Number Avant™ VR Neutrino™ NxT VR Description Connector Type Delivered Energy (approx.
Table 2. Dual-chamber pulse generator descriptions Name Model Number Avant™ DR Description Connector Type Delivered Energy (approx.
Table 3.
These devices can be programmed with Merlin™ Patient Care System equipped with Model 3330 version 25.0.2 (or greater) software. For information on programming, refer to the programmer's on-screen help. Intended Use The Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation.
Table 4. Accessories and their intended uses Accessory Intended use Torque wrench Secure lead connectors and port plugs within the device header.
The intended clinical benefits of the Avant™, Neutrino™ NxT, Gallant™ and Entrant™ Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) may also include the following: Improvement in cardiac function and performance, heart failure symptoms, exercise tolerance, health-related quality of life and well-being, NYHA classification, and functional mitral regurgitation Reduction in heart failure hospitalizations MRI Safety Information MR Conditional ICDs and CRT-Ds are conditionally safe for use in the
Warnings Implantation Procedure The physician should be familiar with all components of the system and the material in this manual, and with the sterile pulse generator implant procedure. The physician should also be familiar with follow-up evaluation and management of patients with an ICD or CRT-D before beginning the procedure. If not, the physician should refer the patient to such a physician.
Storage and Handling Disable tachyarrhythmia therapy (Enable/Disable Tachy Therapy) or program tachyarrhythmia therapies Off during surgical implant and explant or post-mortem procedures, and when disconnecting leads. The device can deliver a serious shock if you touch the defibrillation terminals while the device is charged. For devices without the Low Frequency Attenuation Filter, the default Atrial Sensitivity setting and the lowest possible setting of Ventricular Sensitivity, 0.
Precautions Implantation Procedure Implant the pulse generator no deeper than 5 cm to ensure reliable data transmission. For patient comfort, do not implant the pulse generator within 1.25 cm of bone unless you cannot avoid it. Device Modification This device has been tested for compliance to FCC regulations. Changes or modifications of any kind not expressly approved by Abbott Medical could void the user's authority to operate this device.
be returned to Abbott Medical for inspection. Temperature Equilibrium After cold storage, allow the device to reach room temperature before charging the capacitors, programming, or implanting the device because cold temperature may affect initial device function. Lead Impedance Do not implant the pulse generator if the acute defibrillation lead impedance is less than 20 ¬ or the lead impedance of chronic leads is less than 15 ¬.
Table 5. Possible causes and solutions for suboptimal BLE communication Possible Causes Solutions The BLE dongle orientation or location is suboptimal. Move or reorient the Merlin PCS slightly. Make sure that the BLE dongle faces the implantable device. People or objects interfere with the communication between the Merlin PCS and the device. Make sure that the space between the Merlin PCS and the device is free from interfering objects or people. The BLE dongle is too far away from the device.
generator or deliver a serious shock if you touch the defibrillation terminals while the device is charged. If a programmer is not available, use a magnet to prevent delivery of tachyarrhythmia therapy in response to detected disconnection artifacts. Place the magnet over the pulse generator before disconnecting the leads. Do not remove it until the leads are reconnected. CAUTION: The Magnet Response parameter must be set to Normal for the magnet to prevent the delivery of tachyarrhythmia therapy.
addition, changing cardiac electrical characteristics may prevent detection of a tachyarrhythmia or may cause the pulse generator to misinterpret a normal rhythm as a clinically significant arrhythmia. Changes in medication may require defibrillation threshold testing, updating the morphology template, and reprogramming of the device. Sterilization The package contents have been sterilized with ethylene oxide before shipment. This device is FOR SINGLE USE ONLY and is not intended to be resterilized.
antitachycardia pacing, cardioversion, or defibrillation. Additionally, high-energy induced or conducted currents can reset the programmed parameters and damage the pulse generator and tissue surrounding the implanted lead electrodes. Device Communication Communication with the device can be affected by electrical interference and strong magnetic fields. If this is a problem, turn off nearby electrical equipment or move it away from the patient and the programmer.
cm). - Use the lowest clinically appropriate energy output. - Confirm the pulse generator is functioning following any external defibrillation. The effectiveness of external defibrillation may be reduced due to the insulating effect of the implanted defibrillation electrodes. Minimize this with proper external paddle placement relative to the orientation of the implanted defibrillation electrodes. Deliver the energy perpendicular to a line between the two implanted electrodes.
Therapeutic Radiation Use devices emitting ionizing radiation with caution as they can cause damage to the CMOS circuitry in the pulse generator, which might not be immediately detectable. Devices such as linear accelerators, betatrons and cobalt machines can be used with proper therapeutic planning to minimize cumulative dosage levels to the pulse generator. Diagnostic X-rays, although a source of ionizing radiation, generally produce much lower levels and are not contraindicated.
Diathermy Avoid diathermy, even if the device is programmed off, as it may damage tissue around the implanted electrodes or permanently damage the pulse generator. Ultrasound Therapy The device should not be exposed to therapeutic levels of ultrasound energy, as the device can inadvertently concentrate the ultrasound field and cause harm that might not be immediately detectable. Diagnostic ultrasound treatment is not known to affect the function of the device.
home appliances; arc or resistance welders; equipment with large motors; induction furnaces; very large or defective electric motors; and internal combustion engines with poorly shielded ignition systems. The patient should avoid strong magnetic fields since they are potentially capable of inhibiting tachyarrhythmia therapies.
Minimize radiofrequency ablation risks by: Programming all tachyarrhythmia therapies off Avoiding direct contact between the ablation catheter and the implanted lead or pulse generator Positioning the groundplate so that the current pathway does not pass near the pulse generator.
their patient identification card. If security personnel perform a search with a handheld wand, the patient should ask that they perform the search quickly, stressing that they should avoid holding the wand over the device for a prolonged period. Cellular Phones The pulse generator has been tested for compatibility with handheld wireless transmitters in accordance with the requirements of ISO 14117.
Death Discomfort Embolism Endocarditis Erosion Exacerbation of heart failure Excessive fibrotic tissue growth Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle) Extrusion Fluid accumulation within the device pocket Formation of hematomas, cysts, or seromas Heart block Hemorrhage Hemothorax Hypersensitivity, including local tissue reaction or allergic reaction Infection Keloid formation 21
Myocardial damage Nerve damage Occlusion/Thrombus Pericardial effusion Pericarditis Pneumothorax Pulmonary edema Syncope Thrombosis Valve damage Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death.
Possible adverse device effects include complications due to the following: Abnormal battery depletion Conductor fracture Device-programmer communication failure Elevated or rise in defibrillation/cardioversion threshold Inability to defibrillate or pace Inability to interrogate or program due to programmer or device malfunction Incomplete lead connection with pulse generator Inhibited therapy including defibrillation and pacing Inappropriate therapy (for example, shocks and
Lead migration or lead dislodgement Loss of device functionality due to component failure Pulse generator migration Rise in DFT threshold Rise in pacing threshold and exit block Shunting of energy from defibrillation paddles System failure due to ionizing radiation Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media Breakage or failure of implant instruments Pr
Table 6.
Table 7.
Table 8.
Lead Receptacle Connector Types Table 9.
SVC defibrillation coils and the RV sense/pace electrode into a single connector. The IS4-LLLL lead receptacle can only be used with IS4-LLLL left heart leads. Figure 1. Nominal dimensions of DF4-LLHH lead connector (mm) 1. 2. 3. 4.
Figure 2. Nominal dimensions of IS4-LLLL lead connector (mm) 1. 2. 3. 4. Distal Tip 1 Mid 2 Mid 3 Proximal 4 Sensing The pulse generator has an Automatic Sensitivity Control feature to allow accurate sensing in both the atrium and the right ventricle over a wide range of signal strengths. NOTE: Ventricular sensing is done only in the right ventricle.
Table 10. Ranges for sensitivity settings Parameter Range Atrial Maximum Sensitivity 0.2–1.0 mV Ventricular Defibrillator Maximum Sensitivity 0.3–1.0 mV Ventricular Pacemaker Maximum Sensitivity 0.4–2.0 mV Radiopaque Identification Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the Abbott Medical logo and a two-letter model code.
Table 11. X-ray ID codes for the device models described in this manual Device Model X-ray ID Model Code CDVRA300Q, CDVRA500Q, CDVRA600Q, CDVRA700Q, CDVRA800Q CDDRA300Q, CDDRA500Q, CDDRA600Q, CDDRA700Q, CDDRA800Q CDHFA300Q, CDHFA500Q, CDHFA600Q, CDHFA700Q, CDHFA800Q KM Implanting the Pulse Generator Training Personnel Physicians should be familiar with all components of the system and the contents of this manual before beginning the procedure.
Inspecting and Handling the Device Inspect the packaging before removing the device. Do not implant the pulse generator if: The package is damaged or wet The dot on the ethylene oxide label is purple Purple indicates that the package has not been sterilized. The Use Before Date on the outer box and the tray has been exceeded The Use Before Date reflects the minimum battery voltage required to support the calculated battery longevity shown in the programmer's on-screen help.
Sterile Package and Contents The pulse generator is supplied in a sterile tray for introduction into the operating field. The tray contains: One pulse generator (with all therapies off) with pre-installed setscrews Torque wrench The outer box contains: Literature Opening the Sterile Package To open the package and remove the pulse generator: 1. Peel back the outer tray cover, starting with the corner labeled with an arrow. 2.
Choosing the Implant Site The pulse generator can be implanted in either the pectoral region or the abdominal region, at the physician's discretion. Pectoral Placement Before deciding to implant the pulse generator pectorally, assess patients on a case-by-case basis to ensure their suitability for pectoral implantation. If the device is implanted pectorally, a single incision may be used to form the pocket and provide access for transvenous lead placement.
Abdominal Placement Abdominal placement is recommended for patients who have had previous pectoral surgery or for whom the physician decides that pectoral placement is undesirable for anatomical reasons. Use leads longer than 75 cm with devices implanted abdominally. Implanting the Leads and Testing the Device Forming the Pocket and Connecting the Leads 1. If it has not already been done, prepare a pocket for the pulse generator.
CAUTION: Setscrews are installed in the pulse generator at the time it is shipped. Exercise caution when turning the setscrew, which may be backed out of the connector if turned counterclockwise for more than two rotations. NOTE: When connecting leads to the pulse generator, make sure that you plug the correct lead into the correct lead receptacle.
you hear at least three clicks. Grip the torque wrench by the large part of the handle as shown in the figure on the left below. On applicable models, do not grip the torque wrench by the smaller, narrower part of the handle as shown on the right. Figure 3. Correct vs.
5. Coil any excess lead length underneath the pulse generator in the implant pocket. After implanting the leads, test the lead systems. Because of the difference in capacitance between the pulse generator and an external stimulation device, we strongly recommend device-based testing. However, you may want to use a single, initial test using an external stimulation device to screen for patients with a high defibrillation threshold before you open the pulse generator package. Patient Notifier.
Patient Follow-Up Patients who receive a pulse generator should be seen for follow-up every three months. If the patient experiences a spontaneous episode, it may be deemed appropriate for the patient to return for follow-up immediately.
the inability to deliver therapy or pace, inappropriate shocks, and/or premature battery depletion. Carefully monitor the lead system integrity during patient follow-up for insulation damage or fractures which may result in secondary device failure due to the arcing of current back to the device can. Device Longevity For estimated longevity calculations, see the programmer's on-screen help.
pacing amplitude and high-voltage charge time is changed ATP during charging is disabled CRT-Ds with MPP capability only: MPP is disabled Careful monitoring of the battery status is strongly advised until the pulse generator can be replaced. WARNING: Replace the pulse generator within three months of reaching the ERI indication.
There is no guarantee that the pulse generator will deliver a high-voltage shock after the EOS conditions is detected on the battery. Using a Magnet The pulse generator contains a giant magneto resistor that when activated prevents delivery of tachyarrhythmia therapy. When the magnet is in place and the magnet response is set to Normal, an auditory tone will be present for 4 seconds. If a tone is not detected, the magnet should be moved or another magnet should be tried.
The presence of both a magnet and the programming wand near the implanted device may interfere with telemetry and cause a loss of communication with the programmer. If you need to communicate with the device and use a magnet simultaneously (for example, to confirm proper magnet placement by telemetry), first position the magnet over the device and then place the wand over the device.
therefore should never be incinerated. Out-of-Service/Explant/Patient Death Form Whenever a pulse generator is explanted, or if any of the leads or adapters are replaced or capped, complete an Out-of-Service/Explant/Patient Death form and return it to Abbott Medical with the explanted products. If possible, send along a printout of the programmed settings of the pulse generator. For information on printing reports, see the appropriate reference manual.
Additional Information For additional information on this device, see the programmer's on-screen help. High-Voltage Waveforms Table 12. High-voltage waveforms 1 for 36 J devices Energy Setting Max Min Mean Delivered pulse energy (J) (first shock) 27.7 0.1 15.0 Delivered pulse energy (J) (sequential shock) 32.2 0.1 15.0 Peak ICD output voltage (V) (first shock) 779 64.0 576 Peak ICD output voltage (V) (sequential shock) 836 64.
Table 12. High-voltage waveforms 1 for 36 J devices Energy Setting Max Min Mean 30.7 0.1 14.8 27.2 0.1 13.2 3.5 0.0 1.6 35.9 0.1 17.5 First phase 31.7 0.1 15.6 Second phase 4.2 0.0 1.
Table 12. High-voltage waveforms 1 for 36 J devices Energy Setting Max Min Mean 831 47 584 First phase 831 47 584 Second phase 291 13 201 Max Min Mean 32.0 0.1 15.0 Peak ICD output voltage (V) (sequential shock) Table 13. High-voltage waveforms 2 for 40 J devices Energy Setting Monophasic Delivered pulse energy (J) (first shock) 2 Monophasic and biphasic waveforms at 65% fixed tilt.
Table 13. High-voltage waveforms 2 for 40 J devices Energy Setting Max Min Mean 35.6 0.1 15.0 Peak ICD output voltage (V) (first shock) 850 Peak ICD output voltage (V) (sequential 890 shock) 45 580 45 580 Delivered pulse energy (J) (sequential shock) Biphasic Delivered pulse energy (J) (first shock) 36.0 0.1 17.5 First phase 32.1 0.1 15.6 Second phase 3.9 0.0 1.9 40.0 0.1 17.5 First phase 35.6 0.1 15.6 Second phase 4.4 0.0 1.
Table 13. High-voltage waveforms 2 for 40 J devices Energy Setting Max Min Mean 850 36 593 281 7.0 191 First phase 890 36 593 Second phase 296 7.
Physical Specifications Device Measurements Table 14.
Table 15.
Table 16. Device measurements, CRT-Ds Model Dimensions (l x w x h) (mm) Weight (g) Displaced volume (cm³) Stored energy (J) CDHFA300Q CDHFA500Q CDHFA600Q CDHFA700Q CDHFA800Q 74 x 51 x 12 74 x 51 x 12 74 x 51 x 12 74 x 51 x 12 74 x 51 x 12 76 76 76 76 76 34 34 34 34 34 45 45 45 45 45 Device Materials Table 17. Device Materials Model Can BLE antenna 3 Header Septum All devices Titanium Titanium Elasthane and Epoxy Silicone 3 For devices with BLE telemetry capability.
Noise Detection Table 18. Noise detection Model Noise Detection Rate All devices 100 or more sensed events per second Charge Time Table 19.
Lead Compatibility Table 20. Lead compatibility Device Lead compatibility Single-chamber ICDs (DF4-LLHH) High voltage and RV low voltage: one DF4-LLHH lead connector Dual-chamber ICDs (DF4-LLHH, IS-1) High voltage and RV low voltage: one DF4-LLHH lead connector RA low voltage: one IS-1 3.2 mm bipolar lead CRT-Ds (IS-1, DF4-LLHH, IS4-LLLL) High voltage and RV low voltage: one DF4-LLHH lead connector RA low voltage: one IS-1 3.
Battery Information Table 21. Battery information Device xxxxx300Q, xxxxx500Q, xxxxx600Q, xxxxx700Q, xxxxx800Q Battery chemistry; Manufacturer; Model; Cells Silver vanadium oxide/carbon monofluoride; Greatbatch Medical®; Model 3451; One cell Battery voltage (V) 3.20 (beginning of life) Elective replacement voltage (unloaded) (V) 2.61 End of service voltage (unloaded) (V) 2.54 Past end of service voltage (unloaded) (V) 2.
Device Configurations Table 22.
Table 23.
Table 23.
Table 24.
Table 24.
Inductive Communication While you are conducting the Fibber and NIPS tests using inductive telemetry, ensure that the telemetry wand is at least 2 cm away from and centered over the device. Charging while the telemetry wand is too close may result in a loss of communication when the device charges or dumps the capacitor. If this occurs, the test ends and the device returns to the permanently programmed parameters.
USA: FCC Part 15 Subpart C paragraph 15.247 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: 1. This device may not cause interference, and 2.
Spare Parts and Accessories Only the accessories listed here are approved for use with the pulse generators described in this manual. Table 25. Spare parts and accessories Model Number Name/Description 442-2 Torque wrench AC-0130 Silicone oil 424 Medical adhesive AC-0160 Magnet AC-IP-2 IS-1 receptacle plug 10 AC-IS4PP IS4/DF4 port plug 10 Dual-chamber ICDs and CRTDs only.
Detection Performance in the Presence of Electromagnetic Interference in Differential Mode The Atrial Sensitivity setting of 0.2mV and Ventricular sensitivity 0.3mV (Low Frequency Attenuation Filter ON) may be more susceptible to EMI (as defined by ISO 14117 clause 4.5.2). Atrial Sensitivity of 0.3mV (and less sensitive settings) and Ventricular Sensitivity of 0.3mV and less sensitive settings (Low Frequency Attenuation Filter Off) and 0.
Figure 4. Detection performance in the presence of EMI in differential mode 1. 2. 3. 4. 5. 6. 7. 66 Amplitude (V) Frequency (kHz) Detection Zone No Interference Atrium (0.2 mV) Atrium (0.3 mV) Right Ventricle (0.
Figure 5. Detection performance in the presence of EMI in differential mode (with Low Frequency Attenuation Filter On 11) 1. 2. 3. 4. 5. 6. 7. 8. 9. 11 For devices with the Low Frequency Attenuation Filter only. 67 Amplitude (V) Frequency (kHz) Detection Zone No Interference Atrium (0.2 mV) Atrium (0.3 mV) Right Ventricle (0.3 mV) Right Ventricle (0.
Symbols The symbols below and harmonized symbols may be found on the product or product label. For harmonized symbols, refer to the Universal Symbols Glossary at https://medical.abbott/manuals.
Symbol Description LLLL Quadripolar connector (low voltage, low voltage, low voltage, low voltage) Shipped settings.
Symbol Description Importer RV, DF4-LLHH – RV defibrillation port with quadripolar connector (low voltage, low voltage, high voltage, high voltage) RA, IS-1 Bi - Atrial pacing port with IS-1 bipolar connector; RV, DF4LLHH – RV defibrillation port with quadripolar connector (low voltage, low voltage, high voltage, high voltage) RA, IS-1 Bi - Atrial pacing port with IS-1 bipolar connector; LV, IS4LLLL - LV pacing port with quadripolar connector (low voltage, low voltage, low voltage, low voltage); RV, DF4-L
Symbol Description Unique device identification number European conformity, affixed according to the relevant provisions of AIMD directive 90/385/EEC and RE directive 2014/53/EU Annex II. Hereby, St. Jude Medical declares that this device complies with the essential requirements and other relevant provisions of these directives. The full text of the European Union RE directive 2014/53/EU declaration of conformity is available at the following internet address: www.sjmglobal.com/euconformity.
Symbol Description Follow instructions for use on this website The device contains a battery and the label is affixed to this device in accordance with European Council Directive 2006/66/EC. Return the device to Abbott Medical when explanted or dispose as potentially biohazardous material in accordance with medical practice and applicable local, state, and federal laws and regulations.
St. Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court Sylmar, CA 91342 USA +1 818 362 6822 2019-08 ARTEN100170050 01 St.
