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
Erosion (1750); Hemorrhage/Bleeding (1888); Vomiting (2144); Fluid Discharge (2686)
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Event Date 01/19/2024 |
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, (b)(6).
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Event Description
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It was reported that the deep brain stimulation (dbs) patient had pus coming out of an exposed lead site.It was noted that the patient was also recently ill and vomiting, and later noticed that her incision site started bleeding.The patient underwent an irrigation and debridement to treat the lead site.No devices were explanted.Cultures were performed and the patient was admitted to the hospital for one day with intravenous (iv) antibiotics.
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