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

Model Number	DB-3128-55B
Medical Device Problem Codes	High impedance (1291); Nonstandard Device (1420); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an inadequate therapeutic response and recurrence of pre-existing tremors.Functional testing revealed high impedances.Attempts to reprogram around the high impedances were attempted however were unsuccessful.During the subsequent procedure, the lead extension was found to be bent and was replaced with another lead extension of the same model.Device analysis was not performed, as the component was discarded by the facility.The patient recovered well postoperatively and is currently achieving adequate tremor control.
Additional Manufacturer Narrative
With all the available information (in the absence of product return), boston scientific has concluded that inadequate stimulation, lead extension damage and high impedances are known inherent risks of using the device as documented in the instructions for use (ifu).A review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.The lead extension was discarded by the facility, and 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.Additionally, labeling states failure or malfunction of any part of the device including open circuits, lead extension breakage, loss of adequate stimulation are noted within the ifu and are known inherent risks with the use of deep brain stimulation (dbs).The lead extension was discarded by the medical facility and not returned.As such, physical analysis has not been conducted in our laboratory.However, based on objective evidence from the field and the labeling review, engineers have concluded that inadequate stimulation, lead extension damage and high impedances are known risks of implanting a lead extension as part of a system to deliver dbs.Section b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an inadequate therapeutic response and recurrence of pre-existing tremors.Functional testing revealed high impedances.Attempts to reprogram around the high impedances were attempted however were unsuccessful.During the subsequent procedure, the lead extension was found to be bent and was replaced with another lead extension of the same model.Device analysis was not performed, as the component was discarded by the facility.The patient recovered well postoperatively and is currently achieving adequate tremor control.

• 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: 24610484
• Report Number: 2124215-2026-14433
• Device Sequence Number: 9841834
• Product Code: MHY
• UDI-Device Identifier: 00191506023577
• UDI-Public: (01)00191506023577(17)250430(10)5001023
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 04/30/2025
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5001023
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/22/2026
• Date Device Manufactured: 05/01/2023
• 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: 66 YR
• Patient Sex: Female
• Patient Race: White