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BRIEF-FDA statement on St. Jude Medical's ICD and CRT-D batteries
October 11, 2016 / 1:16 PM / a year ago

BRIEF-FDA statement on St. Jude Medical's ICD and CRT-D batteries

Oct 11 (Reuters) - U.S. Food and Drug Administration:

* U.S. FDA statement on St. Jude Medical Inc’s ICD and CRT-D batteries

* Problems with batteries in St Jude’s ICD, CRT-D batteries manufactured before May 2015 may cause them to run out earlier than expected

* St. Jude Medical has initiated a recall of the devices

* FDA continues to investigate allegations of cybersecurity vulnerabilities related to st. Jude medical cardiac devices, including Merlin@Home monitoring system

* “Strongly recommends that the Merlin@Home device be used” to monitor the battery for affected devices

* Benefits of continued patient monitoring, “life-saving therapy the devices provide greatly outweighs” potential cybersecurity vulnerabilities Further company coverage:

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