Guidant Corp. Issues Warning on Defibrillator Failure

Guidant Corp. has initiated a communication with physicians regarding the clinical performance of its VENTAK PRIZM 2 DR Model 1861 implantable defibrillator, which has been linked to 26 reports of failure, including one recent death. The problem affects approximately 24,000 devices currently implanted worldwide, specifically those manufactured prior to November 2002. The company recommends that patients with the affected device consult their physician if they have questions, but does not advise early replacement. Guidant is working closely with the FDA to address the issue and ensure patient safety.

Key Takeaways:

• 26 reports of failure have been linked to the VENTAK PRIZM 2 DR Model 1861 implantable defibrillator, including one recent death.
• The problem affects approximately 24,000 devices currently implanted worldwide.
• The issue is limited to devices manufactured prior to November 2002.
• Patients with the affected device are advised to consult their physician if they have questions.
• Guidant recommends continued monitoring of patients every 3 months as described in the labeling.
• The company does not advise early replacement of the devices.
• The overall device reliability remains high.
• Guidant is working with the FDA to address the issue and ensure patient safety.

Statistics:

• 26 reports of failure have been linked to the VENTAK PRIZM 2 DR Model 1861 implantable defibrillator.
• 24,000 devices are currently implanted worldwide with the affected model.
• 1 recent death has been reported due to the device failure.
• Devices manufactured after November 2002 are not affected.

Sources:

• Guidant Corp. (GDT) communication to physicians, May 23, 2005.
• Health & Medicine Week editors, Article prepared from staff and other reports.
• NewsRx.com, Agency of News, Health & Medicine Week.