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

Model Number	DB-1408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this deep brain stimulation (dbs) system was replaced due to an unknown reason.The location of the device is unknown.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-extension upn: m365nm3138550 model: nm-3138-55 serial: (b)(6) batch: (b)(6) udi: (b)(4).
Event or Problem Description
It was reported that this deep brain stimulation (dbs) system was replaced due to an unknown reason.The location of the device is unknown.No additional adverse patient effects were reported.Additional information was received stating that the implantable pulse generator (ipg) and lead extension were electively explanted due to the patient having an additional lead implanted for better tremor control.The physician elected replace the battery and single lead extension with a dual-channel battery and two lead extensions.The implant procedure was completed without any device issues, and the tremor has been resolved.The explanted devices will not be returned to boston scientific for analysis, as they were retained by the facility.
Additional Manufacturer Narrative
Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-extension upn: m365nm3138550 model: nm-3138-55 serial: (b)(6).Batch: 7129751 udi: (b)(4).

• 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: 22730894
• Report Number: 3006630150-2025-06198
• Device Sequence Number: 18389812
• Product Code: MHY
• UDI-Device Identifier: 08714729989752
• UDI-Public: (01)08714729989752(17)260406(10)226922
• 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: 2024
• 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): 08/21/2025

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: 04/06/2026
• Device Model Number: DB-1408
• Device Catalogue Number: DB-1408
• Device Lot Number: 226922
• 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: 07/13/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 04/06/2024
• 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: 70 YR
• Patient Sex: Male