BOSTON SCIENTIFIC NEUROMODULATION ARTISAN MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-8416-50 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Paralysis (1997)
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Event Date 01/24/2022 |
Event Type
Injury
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Event Description
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It was reported that following a spinal cord stimulator implant procedure, the patient became paralyzed.A computerized tomography scan was performed, which showed severe spinal stenosis at the level of the implant that was pre-existing but made worse after the implant procedure.The physician assessed that the paralysis was device and procedure related.The patient was admitted to the hospital beyond the standard of care and underwent an explant procedure.The explanted devices will not be returned as they were discarded by the facility.The patient is expected to fully recover.
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Manufacturer Narrative
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Additional suspect medical device components involved in the event product family scs-ipg-pc, upn m365sc14320, model sc-1432, serial (b)(4), batch 206585.
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Search Alerts/Recalls
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