July 18, 2005
Guidant Corp., which last month recalled 100,000 defibrillators, now
says there are problems with some of its pacemakers. The company says
it has notified the FDA, which may order a recall of 28,000
pacemakers currently residing in patients' chests.
The company says as many as 69 of its devices may not be operating properly, either causing the heart to beat too fast or too slowly. At least one patient with an affected pacemaker died, according to the company.
In a statement, Guidant said a subset of the following devices manufactured between November 25, 1997 and October 26, 2000 are affected:
- PULSAR MAX
- PULSAR
- DISCOVERY
- MERIDIAN
- PULSAR MAX II
- DISCOVERY II
- VIRTUS PLUS II
- INTELIS II
- CONTAK TR
Guidant says these products, which are of an earlier generation design, have not been sold or implanted for the last four years.
Guidant said it has determined that a hermetic sealing component used in the subset of devices listed above may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life.
As of July 11, 2005, Guidant has identified 69 devices that may have exhibited this failure mode from approximately 78,000 devices distributed with this component. While no failures have been reported prior to 44 months of service, the likelihood of occurrence increases with implant time.
Guidant estimated the rate of failure in the remaining implanted devices to be between 0.17% and 0.51% over the remaining device lifetime.
Of the 78,000 devices originally distributed, approximately 28,000 devices remain implanted worldwide; 18,000 of these devices remain in service in the United States with an average implant age of 69 months.
"Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients," the company said. "Guidant advises patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate."
Pacemaker failure can cause serious health complications. Guidant said it has confirmed twenty reports of loss of pacing output associated with this failure mode, including five patients experiencing loss of consciousness. Additionally, Guidant said it has received two reports of "sustained Maximum Sensor Rate" pacing in which heart failure may have developed.
In one report, a patient was admitted to the hospital with multiple health issues and later died. The company said it's not clear if pacemaker failure was involved.
