Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 5179111.Product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 7074399.
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It was reported that the patient experienced inadequate stimulation since the original implant procedure.Reprogramming was performed, but there was no improvement.After five months, the patient no longer wishes to continue with the spinal cord stimulator (scs) system and has requested an explant.The patient underwent a revision procedure to explant the whole scs system.All explanted products were discarded by the medical facility.
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