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Withdrawal Notice Issued For Older Pacemakers Due To Malfunctioning of the Device

by Medindia Content Team on  August 3, 2005 at 4:05 PM General Health News   - G J E 4
Withdrawal Notice Issued For Older Pacemakers Due To Malfunctioning of the Device
Health professionals have been recently notified that some older pacemakers manufactured by Guidant Corporation may malfunction due to a build-up of moisture in the device. The products include early generation designs that have not been sold or implanted in the past 4 years, some of the names of the affected models include the Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II, and Contak TR.
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The defect involves a hermetic sealing component that is found to gradually degrade, resulting in a higher than normal moisture content within the pacemaker late in its life.

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The manufacturers say that no failures have been reported in the first 44 months of pacemaker use but the likelihood of occurrence increases with implant time. According to the report there are approximately 28,000 devices that have been implanted worldwide.

Till date there have been 20 confirmed reports of loss of pacing output, including five patients experiencing syncope indicates the report.

The manufactures, Guidant recommends that physicians should consider the unique needs of every patient, but should consider replacing devices for pacemaker-dependent patients, as well as selecting a suitable MSR setting and consider programming the accelerometer to OFF in case of inappropriate sustained pacing at MSR. The manufacturers are also offering a supplemental warranty program to December 31, 2005, with the option of a free replacement device for certain patients.

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