BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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Model Number DB-2202-45 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intracranial Hemorrhage (1891); Convulsion/Seizure (4406)
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Event Date 01/04/2024 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: db-2202-45, model: m365db2202450, serial: (b)(6), batch: 7113620.
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Event Description
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It was reported that the patient experienced a seizure sometime after a deep brain stimulation (dbs) implant procedure.Imaging taken confirmed an intracranial hemorrhage near the left dbs lead, however the serial number to the left lead is currently confirmed.The patient underwent a craniotomy for evacuation procedure.The patient was admitted to rehabilitation until (b)(6) 2024.The patient was released and did well.
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