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

Model Number	DB-1432
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure for an unknown reason.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
Correction to initial report in block h11.Block b3; date of event: approximated based on the date the manufacturer became aware of the event.Block d.2b; additional applicable product codes: mhy and pjs.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.The device was not returned for evaluation; therefore, confirmation of the reported issue through device analysis was not possible.A review of the complaint record and available documentation did not identify additional information that would support further assessment.Consequently, the investigation could not determine a definitive or probable root cause.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure for an unknown reason.

• Brand Name: VERCISE GENUS?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• 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: 22440288
• Report Number: 3006630150-2025-05270
• Device Sequence Number: 4745794
• Product Code: NHL
• UDI-Device Identifier: 08714729985037
• UDI-Public: (01)08714729985037(17)230625(10)205405
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/05/2026

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: 06/25/2023
• Device Model Number: DB-1432
• Device Catalogue Number: DB-1432
• Device Lot Number: 205405
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 05/05/2026
• Date Device Manufactured: 06/25/2021
• 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: 32 YR
• Patient Sex: Male