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

Model Number	DB-1416
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Balance Problems (4401)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in march 2026.Block d2b: additional pro code selection that applies to the indication of this device block d6b: exact date unknown, explant occurred in march 2026.The ipg was not returned for analysis; therefore, a technical analysis could not be performed.However, it was confirmed the ipg met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the event.A review of the instructions for use (ifu) confirmed that gait difficulty and loss of adequate stimulation are known risks associated with use of dbs.Based on a thorough review of the reported complaint boston scientific concluded that the probable cause of the event was unable to be established.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate stimulation that impacted his balance.The patient needed a focused ultrasound and therefore decided to undergo an explant procedure of their dbs device.No further information was able to be obtained despite good faith efforts.

• 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: 25368154
• Report Number: 3006630150-2026-03741
• Device Sequence Number: 10049055
• Product Code: MHY
• UDI-Device Identifier: 08714729985020
• UDI-Public: (01)08714729985020(17)251024(10)223296
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• 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): 06/02/2026

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: 10/24/2025
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 223296
• 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: 05/07/2026
• Initial Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 10/25/2023
• 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: 63 YR
• Patient Sex: Male