NEWS FROM THE INDUSTRY: Safety Announcements
Keywords:
pacemaker, implantable defibrillator, device recalls, pacing lead malfunction, defibrillator lead malfunctionAbstract
Medtronic informs that a software problem has been noticed in the following models: Consulta CRT-D, Secura DR/VR, Concerto II CRT-D, Virtuoso II DR/VR, Maximo II CRT-D, Maximo IIDR/VR. By April, 19 2010 Medtronic has received 5 confirmed reports from 144000 devices none of them associated with adverse effects of any kind. A particular sequence of the following 3 facts must take place within a few ms to cause this problem.
1. The high voltage capacitors obtain the programmed energy (termination of charge)
2. Battery voltage measurement is in progress and
3. The ventricular tachyarrhythmia is self-terminated and the subsequent therapy delivery is postponed.
In that case, all future high voltage therapies would have an elongated charge time or would fail to deliver due to charge circuit time-out. The alert systems of the devices will notify the patients to seek medical attention and this problem will be fixed with a new software installed. The possibility of this malfunction is estimated about 1/27000 devices per year and the possibility of a patient needing therapy before the device alert is activated is about 1/291000 per year... (excerpt)Downloads
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