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

Model Number	DB-1200-S
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure for an unknown reason.The current location of the device remains unknown.No additional adverse patient effects were reported, and no additional information was available.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional pro code selection that applies to the indication of this device product family: dbs-adapters.Upn: m365db9218150.Model: db-9218-15.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional pro code selection that applies to the indication of this device product family: dbs-adapters upn: m365db9218150, model: db-9218-15, serial: (b)(6), batch: 7058970, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure for an unknown reason.The current location of the device remains unknown.No additional adverse patient effects were reported, and no additional information was available.Additional information reveals that the patient undergoing deep brain stimulation (dbs) experienced unexpected shocking sensations.To resolve the issue, a revision procedure was performed, during which both the implantable pulse generator (ipg) and lead were removed and replaced.The patient is recovering well postoperatively and has reported significant improvement.In accordance with facility policy, the explanted device was disposed of and will not be returned.

• Brand Name: VERCISE GEVIA?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 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 Key: 22543513
• Report Number: 3006630150-2025-05637
• Device Sequence Number: 12512789
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)220112(10)741576
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/12/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 741576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/11/2025
• Date Device Manufactured: 01/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female