By Susan Kelly
CHICAGO (Reuters) – 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 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.
Implantable cardiac devices, or ICDs, are used to jolt a
dangerously racing heartbeat back to a normal rhythm. Several
models of the life-saving devices have been the subject of
recalls or safety alerts by Guidant and other manufacturers in
recent years.
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.
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 swooped in to buy Guidant for about $27
billion after Guidant initiated a series of device recalls and
was stung by criticism over its failure to promptly notify
physicians and the public about life-threatening defects.
“We understand and acknowledge we have to do a better job
of communicating, and this is a step in that direction,” Boston
Scientific spokesman Paul Donovan 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, 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.
Morgan Stanley analyst Glenn Reicin said the product
notifications stem from an approach adopted by Guidant last
year to update physicians regularly about performance issues.
“Investors should view these communications as normal
course of business,” Reicin said in a note to clients.
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.
Boston Scientific shares were down 21 cents at $20.49 in
midday New York Stock Exchange trading after initially dipping
almost 3 percent.
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