Bos Sci now under fire for ICD-related patient death
 |
Boston Scientific said in its product performance report that one patient died as a result of the malfunction.
While the company said that the Cognis and Teligen defibrillators are “performing within reliability expectations,” one of its electrical components—the transformer—has been shown to malfunction in some cases. The malfunction has occurred in 26 out of 233,000 (or one out of 8,900) devices implanted.
According to the company, the transformer is used in implantable cardioverter-defibrillators (ICDs) to multiply the low-voltage (approximately 3 volts) of the battery to the high shock voltage (approximately 800 volts).
The Natick, Mass.-based Boston Scientific said the malfunction has occurred during the high-voltage charging cycles and has had the following results:
- Loss of telemetry;
- Loss of bradytherapy;
- Loss of tachytherapy;
- Loss of remote follow-up (patients monitored remotely via the Latitude Patient Management System receive a notification when data from patients’ devices is more than 14 days late); and
- Four patient reports (out of 26 confirmed occurrences) of a sudden heating sensation at the implant site that is likely due to rapid battery depletion.
The patient death was confirmed to be caused by a transformer malfunction that occurred during an automatic capacitor reform.
“Engineering analysis indicates that the probability of malfunction decreases as implant time increases,” according to the paper.
The company offered no additional clinical recommendations in lieu of the notice beyond the current standard of patient care and device labeling.
The following Cognis and Teligen defibrillators use the transformer component:
- Cognis CRT-D N118/N119/N120/P106/P107/P108;
- Teligen DR ICD E110/E111/F110/F111; and
- Teligen VR ICD E102/E103/F102/F103.
Boston Scientific said that it will continue to look into the matter and analyze the failure mechanism on the devices.