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
Undesired Nerve Stimulation (1980); Burning Sensation (2146)
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Event Date 08/19/2021 |
Event Type
Injury
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Event Description
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It was reported that the deep brain stimulation (dbs) patient experienced side effects in the eye when stimulation was on causing burning sensations.The physician attempted to try two different programs to address the eye burning.One where the patient had more severe tremor but better effect on the eye burning, and another where the tremor was better but the eye burning would occur.Mri imaging was performed and revealed the leads were sub-optimally placed.The patient underwent a revision procedure where the leads were replaced.The patient was doing well post-operatively.The explanted leads were retained by the hospital and were not returned to bsc.
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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: 7081903.
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