Boston Scientific admits some implantable cardiac devices have battery problems. Boston Scientific Corp on Monday said it had notified doctors that some of its implantable cardiac devices, which it acquired as part of its purchase of Guidant Corp. last month, could be at risk for early battery depletion.
Boston Scientific, whose shares fell about 1 percent, said the problem occurred in a single lot of 996 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillator devices that had been implanted in patients globally. No deaths or injuries were reported.
Boston Scientific said 30 of its Guidant devices had been returned by May 8, and it had received an additional 46 reports of devices that remained implanted but showed signs of premature battery depletion.
Faulty component from the single manufacturing batch
The devices, which contain a faulty component from the single manufacturing batch, are in the Vitality DS, Vitality AVT and Vitality 2 ICD lines, and the Contak Renewal 3, Contak Renewal 4 and Contak Renewal 4AVF lines of CRT-Ds.
In information posted on its Web site, Boston Scientific advised doctors to schedule follow-up appointments as soon as possible with patients who had received the devices and contact the company for instructions to determine remaining battery life of the devices.
The battery problem came to light after an overall review of Guidant’s product lines, Boston Scientific said.Boston Scientific also advised doctors of two device malfunctions linked with implantation of Guidant defibrillators in an unusual position.
Planting one of these devices below the chest muscle, rather than below the skin
Planting one of these devices below the chest muscle, rather than below the skin, can result in mechanical stress to an area of the titanium case that can cause the product to malfunction, the company said. The uncommon technique could affect devices in the Renewal 3, Renewal 4 and Vitality HE product lines.
The two patients whose devices malfunctioned underwent successful replacement procedures, Boston Scientific said.
Boston Scientific is currently working to resolve a warning letter from the U.S. Food and Drug Administration over quality control issues. The Guidant division also faces its own FDA warning letter over its ICDs.
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