FDAnews Device Daily Bulletin

BOSTON SCIENTIFIC ALERTS PHYSICIANS TO POSSIBLY FAULTY DEFIBRILLATORS

May 16, 2006
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Some Guidant defibrillators may suddenly stop working, jeopardizing the lives of heart-failure patients, Boston Scientific said in a warning letter to physicians dated May 12.

The products in question are the VITALITY HE implantable cardioverter defibrillators (ICDs) and CONTAK RENEWAL 3 and 4 cardiac resynchronization therapy defibrillators (CRT-Ds).

The issue is a faulty capacitor confirmed in 30 defibrillators removed from patients as of May 8, according to the Natick, Mass.-based company. The problem is also suspected in 46 devices that are still implanted in patients. The products come from a lot of 996 devices. There have been no deaths or injuries linked to the device failures, the company noted. The device malfunctioned in two patients who underwent successful replacement procedures, the company said.

The letter to physicians can be viewed at http://www.guidant.com/physician_communications/vit_he_renewal.pdf (http://www.guidant.com/physician_communications/vit_he_renewal.pdf).