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 Problem
Hematoma (1884)
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Event Date 04/24/2023 |
Event Type
Death
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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 m365db2202450, model db-2202-45, serial/lot (b)(6), batch 7099214.
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Event Description
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It was reported that the patient had undergone a deep brain stimulation (dbs) implant procedure.The patient was admitted to the intensive care unit for further care, as the patient was experiencing bleeding and hematoma.The location of the hematoma was at the tip of the dbs lead.The patient did not wake from anesthesia.She had downward gaze and right hemiparesis.The patient subsequently passed away one day post-implant.The physician assessed that the event was procedure related.
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