In the wake of Guidant’s recall fiasco, Boston Scientific takes the Gallant (rather than Goofus) approach to device performance issues. In a response to a product performance review, they’ve uncovered some issues:
The recent physician communications include an advisory describing the potential for premature battery depletion identified in certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured with a single lot of low-voltage capacitors from a single supplier. Only devices from this single manufacturer’s lot — 996 devices implanted worldwide (less than one percent of all implants from these device families) — have exhibited an increased probability of premature battery depletion.
In addition, the Company is providing physicians an advisory reporting two device malfunctions associated with RENEWAL 3, RENEWAL 4 and VITALITY HE devices whose implantation was subpectoral and reversed from the common positioning. Most devices are implanted subcutaneously rather than subpectorally. Testing has confirmed that repetitive mechanical stress applied to a specific area of the titanium case can induce component damage and device malfunction, if the device is implanted in this rarely utilized, uncommon manner. Physicians have been asked to review the specific implant positioning for each patient to determine if any of their patients are affected.
In recent reports, physicians demanded transparency above all else when it came to device issues. Seems like we’re headed in the right direction here.
The press release
More from Guidant (now part of Boston Scientific)