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
Swelling/ Edema (4577)
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Event Date 03/25/2024 |
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: m365db2202450, model: db-2202-45, serial: (b)(6), batch: (b)(6).
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Event Description
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It was reported that the patient experienced encephalitis following a deep brain stimulation (dbs) lead implant procedure and was admitted to the hospital.Imaging taken confirmed an edema surrounding the dbs leads.Tests for infection were performed, however the type of tests performed are unknown.The origin of the encephalitis is unknown however the device was not suspected to have caused it, the edema is a risk of the procedure and infection was ruled out per the physicians assessment.The patient underwent rehabilitation and did well.
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