FCC ID: ESCCRMH21004 Physician’s Technical Manual CONTAK RENEWAL 3 RF MODELS H210/H215 CONTAK RENEWAL 3 RF HE MODELS H217/H219 Cardiac Resynchronization Therapy Defibrillator (CRT-D) Preliminary Draft CONFIDENTIAL RESTRICTED DEVICE: Federal law (USA) restricts this device to sale, distribution, and use by, or on the lawful order of a physician trained or experienced in device implant and follow-up procedures.
1. DEVICE DESCRIPTION Preliminary Draft (partial) CONFIDENTIAL See page 8. The Guidant CONTAK RENEWAL 3 RF cardiac resynchronization therapy defibrillator (CRT-D), Models H210 and H215, and CONTAK RENEWAL 3 RF HE CRT-D, Models H217 and H219, provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD).
vide a variety of therapy options. It also can provide noninvasive diagnostic testing and therapy history data. 1.1. Related Manuals and Information Tools The System Guide for the CONTAK RENEWAL 3 RF is a separate document and is used in conjunction with the Guidant PRM and the Model 2845 software. The System Guide includes product specifications, operating characteristics, implant procedure recommendations, programming instructions, and follow-up recommendations.
suppressible with IV procainamide or an equivalent antiarrhythmic (drug) have not been studied. 3. CONTRAINDICATIONS The CONTAK RENEWAL 3 RF CRT-D is contraindicated for use in the following: • Patients whose ventricular tachyarrhythmias may have reversible cause, such as 1) digitalis intoxication, 2) electrolyte imbalance, 3) hypoxia, or 4) sepsis, or • Patients whose ventricular tachyarrhythmias have a transient cause, such as 1) acute myocardial infarction, 2) electrocution, or 3) drowning. 4.
4.2. Programming and Device Operation • Atrial tracking modes. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF. • Atrial only modes. Do not use atrial only modes in patients with heart failure because such modes do not provide cardiac resynchronization therapy. • Ventricular sensing.
provided the container is intact. If the packaging is wet, punctured, opened, or otherwise damaged, return the device to Guidant. • Storage temperature and equilibration. Recommended storage temperatures are 0°C– 50°C (32°F–122°F). Allow the device to reach room temperature before programming or implanting the device because temperature extremes may affect initial device function. • Device storage.
• Atrial Tachy Response (ATR). ATR should be programmed Off unless the patient has a history of atrial tachyarrhythmias. The delivery of CRT is compromised because AV synchrony is disrupted. • Threshold test. During the left ventricular threshold test, right ventricular backup pacing is unavailable. • Left ventricular pacing only. The clinical effect of left ventricular pacing alone for heart failure patients has not been studied. • Do not bend the lead near the lead–header interface.
• ATR Entry Count. Exercise care when programming the Entry Count to low values in conjunction with a short duration. This combination allows mode switching with very few fast atrial beats. If the entry count were programmed to 2 and the duration to 0, for example, ATR mode switching could occur on two fast atrial intervals. In these instances, a short series of premature atrial events could cause the device to mode switch. • ATR Exit Count. Exercise care when programming the Exit Count to low values.
• Device handling. Program the pulse generator Tachy Mode to Off, disable the magnet feature, and disable the Beep When ERI Is Reached beeper before explanting, cleaning, or shipping the device to prevent unwanted shocks, overwriting of important therapy history data, and audible tones. • Explanted devices. Return all explanted pulse generators and leads to Guidant. 5.5. Environmental and Medical Therapy Hazards • Avoiding EMI.
Following any external defibrillation episode, verify pulse generator function since external defibrillation may have damaged the pulse generator. To verify proper function: interrogate the device, perform a manual capacitor re-formation, verify battery status, check the shock counters, and ensure that programmable parameters did not change.
— Program the Tachy Mode to Off to avoid inadvertent tachycardia detection (sensing) or therapy. — Avoid direct contact between the ablation catheter and the implanted lead and pulse generator. — Keep the current path (electrode tip to ground) as far away from the pulse generator and leads as possible. — Have external defibrillation equipment available. — Consider the use of external pacing support for pacemaker-dependent patients. 5.6. • Home and Occupational Environments Static magnetic fields.
Guidant Corporation 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA 24-Hour Consultation 1.800.CARDIAC (227.3422) Worldwide: +1.651.582.4000 www.guidant.com Preliminary Draft CONFIDENTIAL © 2003 Guidant Corporation All rights reserved.
System Guide Guidant Corporation 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA 24-Hour Consultation 1.800.CARDIAC (227.3422) Worldwide: +1.651.582.4000 www.guidant.com CONFIDENTIAL © 2004 Guidant Corporation All rights reserved.
1-1 INFORMATION FOR USE CHAPTER 1 This chapter contains the following topics: • “Device Description” on page 1-2 • “Indications for Use” on page 1-3 • “Warnings” on page 1-4 • “Precautions” on page 1-5 • “Adverse Events” on page 1-12 • “Summary of Clinical Studies” on page 1-17 • “Device Features” on page 1-51 • “Mechanical Specifications” on page 1-52 • “Maintaining Device Effectiveness” on page 1-53 • “Pulse Generator Longevity” on page 1-53 • “Patient Counseling Information” on page
1-2 INFORMATION FOR USE DEVICE DESCRIPTION DEVICE DESCRIPTION The Guidant CONTAK RENEWAL 3 RF cardiac resynchronization therapy defibrillator (CRT-D), Models H210 and H215, and CONTAK RENEWAL 3 RF HE CRT-D, Models H217 and H219, provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD).
INFORMATION FOR USE INDICATIONS FOR USE 1-3 Related Manuals and Information Tools The Operator's Manual for the Guidant Programmer/Recorder/Monitor provides information specific to the programmer, such as setting up the system, maintenance, and handling. Physician's manuals for the leads provide specific information and instructions regarding the implanted leads.
1-4 INFORMATION FOR USE WARNINGS • Patients whose ventricular tachyarrhythmias have a transient cause, such as 1) acute myocardial infarction, 2) electrocution, or 3) drowning. WARNINGS General • Labeling knowledge. Read this manual thoroughly before implanting the pulse generator to avoid damage to the system. Such damage can result in injury to or death of the patient. • Avoid shock during handling.
INFORMATION FOR USE PRECAUTIONS 1-5 • Ventricular sensing. Left ventricular lead dislodgment to a position near the atria can result in atrial oversensing and left ventricular pacing inhibition. See Sensitivity Adjustment on page 10-4 for more information. • Slow VT. Physicians should use medical discretion when implanting this device in patients who present with slow VT.
1-6 INFORMATION FOR USE PRECAUTIONS programming or implanting the device because temperature extremes may affect initial device function. • Device storage. Store the pulse generator in a clean area, away from magnets, kits containing magnets, and sources of electromagnetic interference (EMI) to avoid device damage. • Use before date. Implant the device system before the USE BEFORE date on the package label because this date reflects a validated shelf life.
INFORMATION FOR USE PRECAUTIONS 1-7 • Threshold test. During the left ventricular threshold test, right ventricular backup pacing is unavailable. • Left ventricular pacing only. The clinical effect of left ventricular pacing alone for heart failure patients has not been studied. • Do not bend the lead near the lead–header interface. Improper insertion can cause insulation damage near the terminal ring that could result in lead failure. • Shock waveform polarity.
1-8 INFORMATION FOR USE PRECAUTIONS atrial intervals. In these instances, a short series of premature atrial events could cause the device to mode switch. • ATR Exit Count. Exercise care when programming the Exit Count to low values. If the Exit Count were programmed to 2, for example, a few cycles of atrial undersensing could cause termination of mode switching. • Left ventricular lead configuration.
INFORMATION FOR USE PRECAUTIONS 1-9 • Device handling. Program the pulse generator Tachy Mode to Off, disable the magnet feature, and disable the Beep When ERI Is Reached beeper before explanting, cleaning, or shipping the device to prevent unwanted shocks, overwriting of important therapy history data, and audible tones. • Explanted devices. Return all explanted pulse generators and leads to Guidant.
1-10 INFORMATION FOR USE PRECAUTIONS Following any external defibrillation episode, verify pulse generator function since external defibrillation may have damaged the pulse generator. To verify proper function: interrogate the device, perform a manual capacitor reformation, verify battery status, check the shock counters, and ensure that programmable parameters did not change.
INFORMATION FOR USE PRECAUTIONS 1-11 — Program the Tachy Mode to Off to avoid inadvertent tachycardia detection (sensing) or therapy. — Avoid direct contact between the ablation catheter and the implanted lead and pulse generator. — Keep the current path (electrode tip to ground) as far away from the pulse generator and leads as possible. — Have external defibrillation equipment available. — Consider the use of external pacing support for pacemaker-dependent patients.
Limited Warranty CONTAK RENEWAL 3 RF MODELS H210/H215 CONTAK RENEWAL 3 RF HE MODELS H217/H219 Cardiac Resynchronization Therapy Defibrillator (CRT-D) Preliminary Draft CONFIDENTIAL
The purchaser must comply with the terms and conditions in this document for this limited warranty to apply. This limited warranty is available if the Guidant device fails to function within normal tolerances due to defects in materials, workmanship, or design during the first 5 years (60 months) for CONTAK RENEWAL 3 RF devices (Models H210/H215) or during the first 4 years (48 months) for CONTAK RENEWAL 3 RF HE devices (Models H217/H219) after date of implantation.
Credit Amount Replacement Date CONTAK RENEWAL 3 RF HE (H217/H219) Full purchase price of either the original unit or the replacement unit, whichever is less 1 to 36 months after implant 50 percent of the above amount decreased on a pro rata daily basis over this 12-month period > 36 to 48 months after implant Guidant does not warrant the suitability of a device for any specific patient, since fitness for use is a medical decision.
2. The device must be replaced with a Guidant CRT-D. 3. The device must be implanted before the “USE BEFORE” date marked on the package. 4. The completed Warranty Validation and Lead Registration form must be returned to Guidant at the time of device implantation, or no warranty exists. 5. The device must be returned to Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St.
