Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: (b)(6).Product family: dbs-ipg-r-mri upn: m365db12160, model: db-1216, serial: (b)(6), batch: (b)(6).
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It was reported that the clinical study (a4010 vercise dbs registry) deep brain stimulation (dbs) patient had developed post-surgical peri-electrode edema, which was moderate in severity.The patient also developed somnolence and confusional syndrome.The patient was admitted to the hospital for several days and was treated with dexamethasone.The physician assessed the event as recovering/resolving with a probable relationship to study procedure, hardware, and stimulation.
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