Medtronic Inc. has advised doctors of a potential battery concern that could cause premature depletion in about 6,300 implanted heart devices, but not without ample warning, the company said Friday.
The issue involves "Concerto" cardiac resynchronization therapy defibrillators, which coordinate beating in erratic hearts and have a defibrillator function to shock hearts to prevent sudden cardiac arrests. The advisory also covers "Virtuoso" implantable defibrillators.
No deaths or injuries have been reported as a result of the issue. Medtronic spokesman Christopher Garland said the potential issue doesn't alter the normal course of regular checkups and device monitoring for patients.
The company guarantees at least a 90-day warning from devices before the battery runs out, and though the battery may not last as long as normal in these devices -- on average, about 5 years -- doctors and patients will still get that warning when the device's alarm goes off.
"There's no safety concern at all, there's been no reports of injury," Garland said.
If a patient's device needs to be replaced, its warranty will likely cover the cost. If the warranty has expired, Medtronic will pay "reasonable medical costs," he said.
Medtronic issued a letter on the matter to doctors earlier this week, Garland noted.
While small in scope, the issue could hurt Medtronic's $5 billion heart-rhythm business, said Bernstein Research analyst Derrick Sung.
