BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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Model Number DB-1216 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/11/2023 |
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-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7113775.Product family: dbs-extension upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7113781.
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Event Description
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It was reported that the patient experienced redness, swelling, and warmth on his chest at the implantable pulse generator (ipg) incision site.Cultures were taken, but the results were not disclosed by the physician.Initially, the patient was prescribed antibiotics, but ultimately underwent an explant procedure where the ipg and extensions were removed.
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Search Alerts/Recalls
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