Guidant’s woes worsened earlier this week after the US devices manufacturer warned of a defect affecting certain of its pacemakers. The announcement comes just weeks after Guidant recalled some 50,000 of its defibrillators after two models were linked to a total of 43 failures and two deaths [[21/06/05e]], and casts a cloud over Johnson & Johnson’s proposed $25.4 billion dollar takeover [[16/12/04a]].
Guidant says that 69 out of a total of 78,000 devices might have failed because of a problem with a sealing component that could have resulted in a higher than normal moisture content within the pacemaker case late in the device’s service life. Of the 78,000 devices originally distributed, approximately 28,000 devices remain implanted worldwide, but they have not been sold or implanted for the last four years.
The company is recommending that doctors consider replacing devices for pacemaker-dependent patients, and that patients seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate. It notes that many of the devices have outlived their warranty, but says that it will provide a replacement device at no charge for pacemaker-dependent patients and other patients deemed to be best served by replacement. The firm will additionally reimburse patients up to $2,500 for medical expenses remaining after health insurance coverage.
As a result of the earlier recalls, Guidant said it would be setting up an independent panel of experts to recommend guidelines for when to inform doctors and patients about life-sustaining implantable devices.