Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. VENTAK PRIZM 2 ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy.
Hazard
Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjuction with other factors, resulted in an electrical short. The short caused diversion of shock therapy energy away from the heart and into device circuitry.
What You Should Do
Dear Doctor letter, dated 05/23/05, was sent to doctors 05/23/05 making them aware of 26 random component failures including one death. Doctors were advised to continue normal monitoring of all patients as indicated in device labeling. Press Release was also issued 05/25/05. Another Dear Doctor letter was dated and issued on 06/17/05. This letter provided updated information to the 05/23/05 letter. The letter gave some indications of device failure and recommendations for normal patient monitoring on routine follow-up visits. Another press release was also issued on 06/17/05.
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