Apparently, an unidentified vendor slipped Boston Scientific some bad capacitors. Said crappy caps found their way into assorted cardiac rhythm management devices. Luckily, no one has died due to device malfunctions.
Some capacitors from specific lots may perform in a manner that leads to device malfunction, including intermittent or permanent loss of therapy or premature battery depletion. To date, a total of five confirmed events have been reported out of approximately 27,200 implanted devices from this subset. One event involved a device malfunction discovered at the time of implant. The other four events involved devices that were implanted and subsequently required replacement.
Patients with affected pacemakers may experience intermittent or permanent loss of output or telemetry, or premature battery depletion. Patients with affected defibrillators may experience inappropriate sensing or premature battery depletion. There have been no reported patient deaths associated with this issue. There have been two reports of pacemaker patients experiencing syncope associated with loss of pacing output.
More detail can be found on the Boston Scientific press page. Kudos to BSX for being transparent on a relatively small (so far) issue. Given that the problem was not (specifically) with a BSX part, but rather a purchased component (that could be any CRM device!), other manufacturers were quick to point they had no such issues…
From St. Jude:
St. Jude Medical Inc. on Tuesday said it has found no reports of faulty components in its implantable heart devices after checking with suppliers in the wake of a recall by rival Boston Scientific Corp. (BSX.N: Quote, Profile, Research)
“We checked and we have no reports of any failures from our suppliers demonstrating this condition,” St. Jude spokeswoman Angela Craig told Reuters.
Medical device maker Medtronic Inc. (MDT.N: Quote, Profile, Research) said on Tuesday its implantable heart devices used different components from those involved in a Monday recall issued by Boston Scientific Corp.
“We know that the capacitors in question are different than the ones used in our products,” said Steve Mahle, president of Medtronic’s cardiac rhythm disease management business, in an alert to its sales force obtained by Reuters.