Monday, May 15, 2006

More Guidant ICD Safety Alerts

I found out today about more Guidant ICD safety alerts for the Vitality HE and Contak Renewal 3 and 4 product lines. The official info can be found on Guidant's webpage for physician communications under the files dated 11 and 12 May 2006. Seems the thin case for these devices (what was once one of their marketing attributes) might not be so great when that defibrillator generator case is put under unusual stress. This stress can be caused by a subpectoral implant (when the device is placed under the breast muscle) and when the serial number is pointed toward the ribs. It seems in certain circumstances this places the circuitry near significant compressive forces (the device hitting the rib) and can short out the device's circuitry. No deaths have been reported, but one patient had a near miss with the pacemaker output failing and he had to be externally paced until a new temporary pacemaker (and eventually a new device) had to be implanted. Only 2 patients have been reported to have had this problem as of 12 May 2006. The incidence of subpectoral implants is VERY low, but realize that this is NOT part of the normally-reported implant data that is stored on registries. (Heart Rhythm Society/FDA, did you HEAR this?) So ask your doctor if you're not sure where your device was implanted, but realize that over 98% of our device implants are NOT subpectoral, and therefore NOT part of this advisory "safety" alert.


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