More bad news from Guidant. From the press release issued this morning by the Guidant Corporation:
A subset of the following devices manufactured between November 25, 1997 and October 26, 2000 are impacted:
PULSAR MAX II
VIRTUS PLUS® II
These products, which are of an earlier generation design, have not been sold or implanted for the last four years.
Guidant 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 sixty-nine (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’s modeling based on field experience and statistical life-table analysis predicts the rate of failure in the remaining active 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.
It is Guidant’s recommendation to physicians that they consider the unique needs of individual patients and the specific technical recommendations set forth in Guidant’s physician communication, dated July 18, 2005. In addition, Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients. In addition, Guidant advises patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.
The clinical behaviors associated with this failure mode can result in serious health complications. Guidant has confirmed twenty reports of loss of pacing output associated with this failure mode, including five patients experiencing syncope.