BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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Model Number DB-1200-S |
Device Problems
High impedance (1291); Unexpected Therapeutic Results (1631); Charging Problem (2892)
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Patient Problems
Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)
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Event Date 04/03/2022 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: product family: dbs-adapters, upn: m365db9218150, model: db-9218-15, serial: (b)(4), batch: 7036227.Product family: dbs-adapters, upn: m365db9218150, model: db-9218-15, serial: (b)(4), batch: 7036230.
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Event Description
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It was reported that the patient was having charging issues.A database analysis was performed and confirmed that the patients stimulation had been off for the past few months.It also confirmed that the patient experienced a reduced charge time and frequency as the battery voltage never dropped below 3.92v.In addition, review of monopolar and bipolar impedances show open contacts, but event counters are within expected normal range.The patient underwent an explant procedure due to four out of eight lead contacts being out of range and the patient experiencing inadequate stimulation.The entire deep brain stimulation (dbs) system was explanted.The patient will be implanted with a new system about a month later.The patient was doing well postoperatively.
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Manufacturer Narrative
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The explanted devices were not returned for analysis, as they were discarded by the medical facility.Physical analysis has not been conducted in our laboratory, therefore, the reported event of the patient experiencing charging issues, high impedances, and inadequate stimulation could not be confirmed.However, a labeling review was conducted for the two lead adapters and a database analysis was conducted for the ipg.The labeling review determined that loss of adequate stimulation is a known inherent risk with use of deep brain stimulation, as documented in the ifu.Additionally, the ipg database revealed that the ipg appeared to be working as expected.Review of the device history record (dhr) and implantable pulse generator (ipg) database for db-1200-s (serial number (b)(6) revealed that the ipg appears to be working as expected.It was confirmed that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.A labeling review was performed for the two lead adapters db-9218-15 (serial numbers (b)(6) and it did not reveal any anomalies as it states that malfunction of any part of the device, including but not limited to: battery leakage, battery failure, lead or extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits, and lead insulation breaches, whether or not these problems require device removal and/or replacement, and loss of adequate stimulation are known risks with the use of deep brain stimulation.
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Event Description
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It was reported that the patient was having charging issues.A database analysis was performed and confirmed that the patient's stimulation had been off for the past few months.It also confirmed that the patient experienced a reduced charge time and frequency as the battery voltage never dropped below 3.92v.In addition, review of monopolar and bipolar impedances show open contacts, but event counters are within expected normal range.The patient underwent an explant procedure due to four out of eight lead contacts being out of range and the patient experiencing inadequate stimulation.The entire deep brain stimulation (dbs) system was explanted.The patient will be implanted with a new system about a month later.The patient was doing well postoperatively.
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