Additional suspect medical device component involved in the event: model#: sc-8336-50 serial #: (b)(4) description: coveredge 32, 50 cm 4x8 surgical lead the explanted devices were not returned to bsn as they were discarded by the medical facility.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
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