A Medical Device Daily
Guidant (Indianapolis) yesterday afternoon released a statement acknowledging that it has “initiated a communication to physicians” concerning problems with its Ventak Prizm 2 DR Model 1861 implantable cardiac defibrillator (ICD).
The statement confirmed the report by the New York Times earlier this week that there has been one death as a result of the device’s malfunction, plus 26 other reports of device “failure” (Medical Device Daily, May 25, 2005).
The company also reportedly met with the FDA on Tuesday to discuss the device failure.
In its statement, Guidant said it issued a letter to physicians, dated May 23, describing what it termed as “a rare failure that results in the device’s inability to deliver therapy,” with the problem only in its Ventak Prizm 2 DR ICDs manufactured before November 2002. Devices manufactured after this date, it said, “are not affected.”
Patients with these devices, Guidant said, “should consult with their physician” about questions concerning the device, “particularly if they have recently received a defibrillation shock.” And it recommended monitoring of these patients “every three months as described in the labeling.”
It did not recommend “early” device replacement, saying that “overall device reliability remains high.”
The company said it has worked with the FDA on the issue and would continue to do so, “including any subsequent communication that may be helpful for patients or physicians.” It said that in addition to public regulatory and performance reporting, it will “continue to undertake further specific physician communications to improve patient outcomes or limit adverse events related to device behavior.”