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Guidant Issues Advisory on Early ICD Battery Depletion
from Heartwire a professional news service of WebMD
April 11, 2007 (St Paul, MN) - The Boston Scientific division Guidant is warning physicians and patients [1,2] that some models of its Vitality, Vitality 2, and Contak Renewal 3 and 4 lines of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices may require early replacement due to premature battery depletion .
The problem, which is caused by "low-voltage capacitors from a former supplier," could potentially cut the interval between the elective replacement indicator and the battery's end of life to less than three months, according to the company. It cites 19 confirmed cases of the early battery depletion, out of about 73 000 devices in use worldwide, and says no one has died or been seriously injured as a result of the problem.
Guidant's safety advisory, which the FDA has classified a "recall" and which lists the specific models involved and provides guidelines for following patients now using them, says they have been withdrawn from distribution and are being retrieved from hospital shelves.
Boston Scientific. Product advisory--Potential for reduced ERI to EOL time due to low-voltage capacitor degradation in a subset of ICDs and CRT-Ds [letter to physicians]. April 5, 2007. Available at:
Boston Scientific Product advisory letter [letter to patients]. April 5, 2007. Available at: http://www.guidant.com/patient/communication/AP_Shortened_Replacement_Window.pdf.
Guidant. Safety advisory. April 5, 2007. Available at: http://www.guidant.com/ppr/advis/2007_04_05.shtml.
Food and Drug Administration. Boston Scientific / Guidant recall: Questions & answers. April 10, 2007. Available at: http://www.fda.gov/cdrh/news/guidantrecall.html.
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