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
Wound Dehiscence (1154); Impaired Healing (2378)
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Event Date 10/05/2023 |
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, serial: (b)(6), batch: 7084175.
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Event Description
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It was reported that the deep brain stimulation (dbs) patient underwent an irrigation and debridement procedure due to the incision not healing properly.Bipolar electrocautery was used while the implantable pulse generator (ipg) was turned off.Per the physicians implant manual, electrocautery can transfer destructive current into the dbs leads and/or stimulator.No products were explanted or implanted.The patient was discharged the same day and was doing well postoperatively.
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