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
Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/26/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient had an infection at the implantable pulse generator ipg site.The patient's symptoms included redness.The patient was administered antibiotics and underwent a procedure where the ipg was explanted, and the lead extensions were cut in the pocket.Post operatively, the patient was noted to have recovered.Cultures were taken but results are unknown.
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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: 7109751.Product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(6); batch: 7109896.
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