BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-2218-70 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Paralysis (1997); No Code Available (3191)
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Event Date 10/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2218-50, serial: (b)(4), batch: 5159604.Product family: scs-lead fixation, upn: (b)(4), model: sc-4318, serial: n/a, batch: 25835826.
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Event Description
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It was reported that following a lead implant procedure, the patient was experiencing reduced motor control in legs.The physician removed the leads and clik anchors.
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Manufacturer Narrative
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Correction to initial mdr in field b6.Visual inspection of sc-2218-70 (serial number (b)(6)) and sc-2218-50 (serial number (b)(6)) revealed that the lead was cleanly cut into two pieces.The clean-cut damage is a result of a typical explant procedure and it is not considered a failure.No other anomalies were identified on the returned clean-cut leads.The returned clik anchor was analyzed, passed all tests performed, and exhibited normal device characteristics.The investigation concluded that the reported event was not confirmed through device analysis.Therefore, a probable cause cannot be determined as no problem has been detected.
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Event Description
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It was reported that following a lead implant procedure, the patient was experiencing reduced motor control in legs.The physician removed the leads and clik anchors.Additional information was received that patient is recovered.
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