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); Dysphasia (2195); Cognitive Changes (2551)
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Event Date 03/16/2022 |
Event Type
Injury
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Event Description
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It was reported that following a deep brain stimulation (dbs) implant procedure, the patient experienced a hemorrhage resulting in significant dysarthria and cognitive disruption.The patient is undergoing physical therapy.The dbs system is functioning and remains implanted in the patient.
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(4), lot: 7078566.
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Search Alerts/Recalls
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