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	Unexpected Therapeutic Results (1631); Charging Problem (2892)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced difficulty charging, as well as forgetting to charge, the implantable pulse generator (ipg) of the deep brain stimulation (dbs) system causing a loss of therapy and symptoms of rigidity.The patient underwent a revision procedure in which the rechargeable ipg was replaced with a primary cell device and is doing wel lpost operatively.The device was not returned as it was retained by the facility.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes that the cause of the patient experiencing inadequate stimulation due to difficulty charging and undergoing an ipg replacement procedure could not be confirmed.The device was retained by the facility, and device analysis could not be done.A review of the manufacturing records associated with the device indicated that it was successfully processed according to requirements.The device history review, dhr, did not identify any manufacturing process-related non-conformances, scrap, or rework performed during production that could have caused or contributed to this event.The dhr review ensures each device meets required specifications and associated testing prior to release for distribution/sale.The device was not returned for analysis; therefore, a technical analysis could not be performed.A labeling review was performed on the device's instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.It states failure or malfunction of any part of the device, including but not limited to battery leakage, battery failure, hardware malfunctions, whether or not these problems require device removal and/or replacement, loss of adequate stimulation and stiffness in muscles or joints are known risks with the use of system.Based on all available information, engineers are not able to confirm the root cause of the event.The device was not returned, as such, physical analysis could not be conducted in our laboratory.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable root cause for the complaint, and the conclusion is cause not established.

• 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: 25225535
• Report Number: 3006630150-2026-03319
• Device Sequence Number: 9792294
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)220923(10)744418
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/23/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 744418
• 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: 04/22/2026
• Initial Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 09/23/2020
• 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: 65 YR
• Patient Sex: Female