Some Medtronic ICD, CRT-D devices could have faulty battery, company warns physicians

February 14, 2005

Minneapolis, MN - A risk of rapid battery depletion has been discovered in some of Medtronic's MarquisTM and MaximoTM implantable cardioverter-defibrillators (ICDs) and InSyncTM cardiac resynchronization therapy-defibrillator (CRT-D) devices, Medtronic has warned physicians. The potential problem is limited to models manufactured between April 2001 and December 2003, the company announced. About three fourths of the affected devices were implanted in the US, it said. No recall has been issued.

Models affected by the warning

Model 7230 MarquisTM VR

Model 7274 MarquisTM DR

Model 7232 MaximoTM VR

Model 7278 MaximoTM DR

Model 7277 InSync MarquisTM

Model 7289 InSync II MarquisTM

Model 7279 InSync III MarquisTM

Model 7285 InSync III ProtectTM (none implanted in the US)

Source: Medtronic Inc

During tests of devices returned to the company by physicians, Medtronic identified a problem that could cause the battery to short and lead to loss of energy reserves within "a few hours to a few days," according to the company. The faulty batteries were identified in nine devices of about 87 000 implanted, or 0.01%.

"Based on highly accelerated company testing, Medtronic estimates that this rate may increase to between 0.2% and 1.5% over the second half of device life." No patient injuries or deaths related to the problem have been reported, according to the company.

Medtronic began voluntarily notifying doctors of the problem on February 10, it said, "providing them with a list of potentially affected patients and recommending that physicians communicate with those patients and follow them closely." Physicians should handle the issue "as they feel is appropriate with their individual patients."

Both patients and clinicians can find further information about the faulty battery risk at the Medtronic information center on the web or by calling 1-888-775-2702.


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