Medtronic Inc. confirmed to the Wall Street Journal that is sent an advisory letter to doctors warning of potential problems with the batteries in its Concerto cardiac resynchronization therapy and Virtuoso defibrillators.
It seems that about 6,300 of the implantable CRTs’ batteries could become “prematurely depleted,” the newspaper reported, but not before providing a warning 90 days ahead of time.
Medtronic spokesman Chris Garland told the Journal that Medtronic identified the issue and it doesn’t change the normal course of treatment and monitoring for patients with the devices.
“There’s no safety concern at all, there’s been no reports of injury,” Garland said.
It’s another blow to Medtronic’s hopes of resuscitating its heart rhythm business, which has suffered under a series of problems with its defibrillators.
First, in 2007, came the death of at least 18 patients after its now-recalled Sprint Fidelis defibrillator leads fractured. Next was the June recall of 21,000 of its Kappa and Sigma series implantable pacemakers (Medtronic estimates more than 1.7 million have been implanted in patients worldwide) after problems with their wiring emerged.