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
Incontinence (1928); Cognitive Changes (2551); Movement Disorder (4412); Speech Disorder (4415)
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Event Date 10/28/2022 |
Event Type
Injury
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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)(6), batch: (b)(6).
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Event Description
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It was reported the patient experienced speech and mobility difficulties, cognitive impairment and issues with incontinence following a revision procedure (reported in mfr# 3006630150-2022-06394) to replace the deep brain stimulation (dbs) leads.The patient underwent additional care with a neurologist, speech therapist, and physical therapist.
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Search Alerts/Recalls
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