Guidant Notifies Physicians Regarding Implantable Defibrillator

Guidant initiated a communication to physicians regarding the clinical performance of its Ventak Prizm 2 DR Model 1861 implantable defibrillator.

There have been 26 reports of failure, including one recent death, the company acknowledged. Approximately 24,000 of the devices are currently implanted worldwide. The devices contain a flaw that could result in their inability to deliver therapy. The affected Prizm 2 defibrillators were manufactured prior to November 2002; devices manufactured after this date are not affected.

Patients with a Prizm 2 defibrillator should consult their physicians if they have questions regarding their device, particularly if they have recently received a defibrillation shock. Guidant recommends that physicians continue monitoring patients every three months as described in the labeling and does not recommend early replacement of these devices. The company is working with the FDA on this issue, including releasing any subsequent communication that may be helpful for patients or physicians.