St. Jude Medical urged physicians Friday to stop implanting its Nanostim leadless cardiac pacemaker, citing concerns over electronic data issues and reports of battery malfunctions, according to a Reuters report.
Here are four things to know.
- The Saint Paul, Minn.-based drugmaker received seven reports of lost telemetry and heart pacing output from the pacemakers, according to the report. The problems surfaced 29 to 37 months after the device was implanted.
- Out of the 1,423 devices implanted in patients across the globe, 1,397 are still in service, representing a potential risk to patients, St. Jude said.
- The company issued a letter to physicians, instructing them not to implant any more Nanostim pacemakers into patients. Any devices in stock should be returned to the company. St. Jude recommends device replacement for any patient implanted with the device.
- According to St. Jude, there have been no reports of injury related to the device malfunction.
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