n”>Medical device maker St. Jude Medical Inc said on Friday it has notified doctors to stop implants of one of its cardiac pacemakers, citing reports of problems with electronic data reporting caused by a battery malfunction that could put patients at risk.
The affected device is the Nanostim leadless cardiac pacemaker (LCP). St. Jude, which is being acquired by Abbott Laboratories, said it had seven reports of lost telemetry and heart pacing output from the devices.
Of a total of 1,423 Nanostim devices implanted worldwide, 1,397 remain in service and represent a potential risk to patients, the company warned.
There have been no reports of patient injury associated with the malfunction, St. Jude said.
“We are currently working to ensure our physician partners worldwide have the information they need to effectively manage their patients,” St. Jude Chief Medical Officer Mark Carlson said in a statement, adding that the company remains committed to developing leadless pacing technology.
In a letter to doctors, St. Jude said they should not implant any Nanostim pacemakers they might have in stock and instead return them to the company. It said device replacement is recommended, with priority given to patients with implants of the longest duration.
