St. Jude Warns of Possible Pacemaker Problems
Company officials said that less than 1% of the devices might be affected and that no patient injuries have been reported thus far.
The company is not recommending replacement of the pacemakers, but physicians might decide to replace the device's generator. St. Jude spokesman Peter Gove said that physicians should receive the warning letters by Friday.
This is the third such warning issued by St. Jude this year. In January, the company voluntarily recalled heart valve products containing its Silzone coating after a study found too many of the products had to be removed after implant because of post-operative leaking (see St. Jude Medical Recalls Certain Heart Valves). In February, St. Jude said that some of its pacemakers could malfunction because of an electrical connection problem. The warning involved the company's Affinity pulse generators, models 5330, 5130, and 5230 (see St. Jude Warns of Pacemaker Defect).
Source: Associated Press and Reuters news reports