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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

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BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-1200-S
Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Charging Problem (2892)
Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)
Event Date 04/03/2022
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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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Brand Name
VERCISE GEVIA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key16074604
MDR Text Key306404891
Report Number3006630150-2022-07387
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729984443
UDI-Public08714729984443
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/13/2021
Device Model NumberDB-1200-S
Device Catalogue NumberDB-1200-S
Device Lot Number738382
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2022
Initial Date FDA Received12/29/2022
Supplement Dates Manufacturer Received02/06/2023
Supplement Dates FDA Received03/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient SexFemale
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