Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 21086447.Product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 21086447.
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With all available information, boston scientific concludes the reported event of inadequate stimulation was unable to be confirmed as the devices passed all tests performed.Laboratory analysis of the returned devices did not identify any product performance- related issues.Device technical analysis: the returned ipg sc-1132 serial number (b)(6) passed the functional test and revealed no anomalies.The leads sc-2317-70 serial number (b)(6) were returned and analyzed.The leads were cleanly cut, and 8 cm of the proximal end portions were returned.No anomalies were identified on the leads aside from the clean-cut.The damage to the leads is a result of a typical explant procedure.
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