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

Model Number	DB-1232
Medical Device Problem Codes	Nonstandard Device (1420); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced non-device related heart issues wherein defibrillation was required.The defibrillator was placed directly over the implantable pulse generator (ipg) during defibrillation.Approximately two weeks later it was determined that the ipg battery was fried and needed to be replaced as the ipg was unable to hold any charge.The patient underwent a revision procedure where the ipg was replaced.The patient was doing well postoperatively.The explanted device was retained by the hospital and was not returned.

• Brand Name: VERCISE GENUS?
• 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: 24058174
• Report Number: 3006630150-2026-00308
• Device Sequence Number: 21303139
• Product Code: PJS
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)270422(10)786956
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 01/13/2026

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 Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 786956
• 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: 12/18/2025
• Initial Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 04/22/2025
• 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: 74 YR
• Patient Sex: Male