BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number DB-2201-45-DC |
Device Problems
High impedance (1291); Low impedance (2285)
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Patient Problem
Movement Disorder (4412)
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Event Date 01/11/2024 |
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-extension, upn: m365db312895b0, model: db-3128-95b, serial: (b)(6), batch: 5000181.
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Event Description
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It was reported that the deep brain stimulation (dbs) patient experienced inadequate dystonia coverage.Impedances were observed and two surgeries were performed to identify the source of the impedances.The physician initially replaced the lead but the impedances remained, so a second revision was performed to replace the lead extension.The patient was doing well post-operatively.
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: product family: dbs-extension, upn: m365db312895b0, model: db-3128-95b, serial: (b)(6), batch: 5000181.
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Event Description
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It was reported that the deep brain stimulation (dbs) patient experienced inadequate dystonia coverage.Impedances were observed and two surgeries were performed to identify the source of the impedances.The physician initially replaced the lead but the impedances remained, so a second revision was performed to replace the lead extension.The patient was doing well post-operatively.Additional information received indicates that the explanted lead was discarded by the facility.
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