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

Model Number	DB-3128-55B
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an elective deep brain stimulation (dbs) implantable pulse generator (ipg) revision procedure, the lead extension appeared bent and cracked upon removal from the ipg header.The physician noted that the patient has a difficult time speaking and could not confirm any adverse events and the cause of the damage to the lead extension are unknown.The lead extension was replaced with another of the same model, and the procedure was completed successfully.Analysis of the damaged lead extension was not performed, as it was retained by the facility.The patient recovered well post-operatively.
Additional Manufacturer Narrative
Block d2b: additional pro codes, nhl, pjs.
Additional Manufacturer Narrative
Based on the available information (in the absence of product return) boston scientific concludes that the cause of the bent and cracked lead extension upon removing from the ipg header could not be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.The lead extension was retained by the facility, as such physical analysis has not been conducted in our laboratory.A product labeling review identified that the device was used per the ifu product label.The lead extension was retained by the facility.As such, physical analysis has not been conducted in our laboratory.However, based on objective evidence from the field, engineers have concluded that bent and cracked lead extension upon removing from the ipg header cause could not be established.
Event or Problem Description
It was reported that during an elective deep brain stimulation (dbs) implantable pulse generator (ipg) revision procedure, the lead extension appeared bent and cracked upon removal from the ipg header.The physician noted that the patient has a difficult time speaking and could not confirm any adverse events and the cause of the damage to the lead extension are unknown.The lead extension was replaced with another of the same model, and the procedure was completed successfully.Analysis of the damaged lead extension was not performed, as it was retained by the facility.The patient recovered well post-operatively.

• Brand Name: VERCISE
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22351537
• Report Number: 2124215-2025-43029
• Device Sequence Number: 15585213
• Product Code: MHY
• UDI-Device Identifier: 00191506023577
• UDI-Public: (01)00191506023577(17)260425(10)5002880
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 04/25/2026
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5002880
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 04/25/2024
• 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
• Patient Race: White