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
Abscess (1690); Unspecified Infection (1930); Speech Disorder (4415)
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Event Date 09/26/2021 |
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)(4), lot: (b)(4),.
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Event Description
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It was reported that the patient developed an abscess at the deep brain stimulation lead site on the right side.Therefore, the patient underwent a procedure to remove the lead.The procedure was somewhat longer than expected due to the patients blood pressure dropping which was addressed with anesthesia.The lead was removed once the patient was stable.The patient underwent an additional procedure three days later where the area was washed out and a drain was installed.The patient remains in the hospital as he experienced speech deficits, yet he is improving.There was no indication of the infection being device related.The lead was retained by the medical facility.
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Search Alerts/Recalls
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