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); Use of Device Problem (1670); Low impedance (2285); Delayed Charge Time (2586); Charging Problem (2892)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a cardiac ablation procedure.Following the procedure, the patient observed that the implantable pulse generator (ipg) battery indicator displayed a low status on the remote control.The patient reported that the device required daily charging over extended intervals in order to maintain adequate battery function.Subsequent impedance testing demonstrated low impedance values, and the patient later experienced a loss of stimulation due to complete battery depletion, which resulted in the recurrence of tremor.The patient underwent an ipg revision procedure and is expected to fully recover.
Additional Manufacturer Narrative
The returned deep brain stimulation (dbs) implantable pulse generator (ipg) would not charge despite the multiple charging attempts, and communication could not be established with a remote control (rc) or clinician programmer (cp).As a result, data logs could not be retrieved or analyzed, and functional testing could not be performed.Further investigation confirmed that the application-specific integrated circuit (asic) chip was damaged, which accounts for the reported allegation.This type of damage is typically associated with exposure to external high voltage or high current transient sources.A labeling review did not reveal any anomalies.Accordingly, the investigation assigns a probable cause of unintended use error caused or contributed to event.Based on available information, the ipg was likely damaged during the cardiac ablation procedure.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a cardiac ablation procedure.Following the procedure, the patient observed that the implantable pulse generator (ipg) battery indicator displayed a low status on the remote control.The patient reported that the device required daily charging over extended intervals in order to maintain adequate battery function.Subsequent impedance testing demonstrated low impedance values, and the patient later experienced a loss of stimulation due to complete battery depletion, which resulted in the recurrence of tremor.The patient underwent an ipg revision procedure and is expected to fully recover.

• 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: 23754018
• Report Number: 3006630150-2025-11282
• Device Sequence Number: 14925651
• Product Code: PJS
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)211014(10)740516
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 02/23/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/14/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 740516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• 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: 75 YR
• Patient Sex: Male
• Patient Race: White