The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs) manufactured by St. Jude Medical. The affected models are CD1277 (-36 and -36Q), CD1377 (-36, -36Q, -36C and -36QC), CD2277 (-36 and -36Q) and CD2377 (-36, -36Q, -36C and -36QC). ICDs with serial numbers beginning with "1" that are below 1132470, beginning with the number "7" that are below 7126267 and all serial numbers beginning with an "8" are affected.
The manufacturer has received complaints that extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices. As designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value.
This anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock.
According to the manufacturer, there have been no reported cases of an Ellipse device failing to deliver high voltage therapy to a patient when needed.
The manufacturer is providing appropriate patient management recommendations to surgeons for managing patients who are implanted with the affected devices.
Furthermore, the manufacturer advises customers that the affected stock will be retrieved and replaced by new Ellipse ICDs with the redesigned high voltage capacitor eliminating the source of capacitor damage at the front alignment hole.
For details, please refer to TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00905-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 August 2014