Additional suspect medical device components involved in the event: model#: sc-8216-50 serial#: (b)(4) description: artisan surgical lead, 50cm model #: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator the explanted devices were not returned to bsn as they were kept 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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