December 28, 2005
This is an update of our July 14 and October 13, 2005 Preliminary Public Health Notifications (PPHNs) about malfunctions occurring with Guidant’s PRIZM® 2 and CONTAK RENEWAL® implantable cardioverter defibrillator (ICD) devices, which were the subjects of a Class I recall announced by the Food and Drug Administration (FDA) on July 1, 2005. A device subject to this recall may develop an internal short and fail when it attempts to provide a defibrillation shock. Failure to provide a needed defibrillation shock is a serious, life-threatening event.
The information provided in this updated PPHN does not change our earlier recommendations about clinical management of patients with these devices but is intended to provide patients and physicians with the most up-to-date data, allowing them to make fully informed decisions.
The affected devices are:
- VENTAK PRIZM® 2 DR, Model 1861, manufactured on or before April 16, 2002
- CONTAK RENEWAL®, Model H135, manufactured on or before August 26, 2004
- CONTAK RENEWAL® 2, Model H155, manufactured on or before August 26, 2004
We are providing this update because Guidant has informed us of 14 additional clinical occurrences exhibiting this failure mode for the Contak Renewal® and Renewal® 2 devices since our October 13, 2005 PPHN. As of December 21, 2005, a total of 35 clinical failures (of which FDA has confirmed 20), including 5 patient deaths, have been reported worldwide. You should take these failures into account as you continue to follow the patients who have either RENEWAL model subject to the recall.
Guidant has also informed us of 4 additional clinical failures for the Ventak Prizm® 2DR since our October 13, 2005 PPHN, including one patient death. As of December 21, 2005, a total of 32 clinical failures (of which FDA has confirmed 30), including 2 patient deaths, have been reported worldwide. You should take these failures into account as you continue to follow patients who retain the affected Prizm® 2 DR.
There are likely to be additional clinical occurrences in the future, and we will provide updates as this information becomes available.
Summary of July 14 and October 13, 2005 Preliminary Public Health Notifications
Degraded insulation in these devices can lead to the inappropriate shorting of a defibrillation pulse back into the circuit. This can damage the circuit, resulting in an inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. At the time of the July 14, 2005 PPHN, at least two deaths attributable to this failure mode had been reported. At the time of the October 13, 2005 Update, at least 4 deaths were attributable to this failure mode. We recommended replacement of any device that had demonstrated the failure mode. We recommended that, in the absence of demonstrated failure, the decision about replacement be made by the patient in consultation with his or her physician and should be based on the patient’s condition, medical history, and other pertinent factors. We also provided recommendations for follow-up of patients who retain the device. Because there are no signs of impending device failure, and there is no test that predicts whether or when any particular device will fail, FDA concluded that there is insufficient evidence to support the value of a commanded shock as a means to check for pending failures.
The FDA has not changed these recommendations.
Reporting Adverse Events to FDA
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of a Guidant ICD, you should follow the reporting procedure established by your facility. Prompt reporting of adverse events can improve FDA’s understanding of and ability to communicate the risks associated with devices and assist in the identification of potential future problems.
We also encourage you to report adverse events related to ICDs that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787. Consumers can also report directly to MedWatch.
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
Daniel G. Schultz, MD
Center for Devices and Radiological Health
Food and Drug Administration
* CDRH Preliminary Public Health Notifications are intended to quickly share device-related safety information with healthcare providers when the available information and our understanding of an issue are still evolving. We will revise them as new information merits and so encourage you to check this site for updates.