St. Jude Warns of Pacemaker Defect

St. Jude Medical Inc. (St. Paul, MN) said last week that some of its pacemakers could malfunction because of an electrical connection problem. The warning concerns Affinity pulse generators, model 5330 and 5130 in the United States, and models 5330, 5130, and 5230 outside of the United States.

In a letter sent to physicians, the company said that "conductive material used to secure a resistor to the device circuitry may not provide continuous and proper electrical connection in this small population of devices."

The potential problem is limited to 891 devices that were shipped during June 1999. The company believes that the problems will affect approximately 10% of the devices over a 5-year period, with more than half of those occurring within the first year of shipping.

Such a defect could cause the device to malfunction, including exhibiting abnormal measured battery data, showing a false replacement indication, or developing output anomalies, including intermittent loss of output. The company said that, to date, 33 devices had exhibited one or more of these behaviors.

Last month, St. Jude 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).

Edited by Ursula Jones