BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-8336-50 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Hemorrhage/Bleeding (1888); Paralysis (1997); Thrombosis/Thrombus (4440)
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Event Date 04/13/2021 |
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-ipg-r-mri, upn: m365sc12320, model: sc-1232, serial: (b)(4), batch: 505432.
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Event Description
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It was reported that the patient had complications of bleeding, hematoma and paralysis of both legs as a result of a blood clot formed by the paddle lead during an implant procedure.The patient immediately underwent an explant procedure of the ipg and paddle lead.The patient was noted to be doing great post procedure and regained all functionality.The explanted devices were not returned.
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