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

Model Number	DB-1232
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Implant Pain (4561)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d2b additional pro codes, nhl, pjs.Additional suspect medical device components involved in the event: model/catalog description: 55cm 2x8 lead extension kit model: db-3128-55b, serial: (b)(6), batch: 5004563, udi: (b)(4).Model/catalog description: dbs 2x8 extension 55cm sterile kit model: db-3128-55, serial: (b)(6), batch: 5005015, udi: (b)(4).
Event or Problem Description
It was reported that the patient implanted with a deep brain stimulation (dbs) to treat pain, experienced pain localized at the implantable pulse generator (ipg) chest incision site.Pain medication was administered; however, the symptoms persisted.The patient subsequently underwent removal of the ipg and lead extensions prior to completion of the procedure.In the physicians opinion, the infection was procedure-related and associated with the incision.Device analysis was not performed, as the components were discarded by the facility.The patient was treated with antibiotics and recovered well postoperatively.
Additional Manufacturer Narrative
Product analysis review for models db-1232 serial number (b)(6) db-3128-55b, serial number/s (b)(6) and (b)(6) has been completed (in the absence of product return).With all the available information, boston scientific has concluded that implant pain and infection 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 devices were discarded by the facility as such device analysis was not completed.A product labeling review identified that the devices were implanted off label to treat pain which is not in the ifu product label.Additionally, labeling states boston scientifics deep brain stimulation (dbs) is indicated for use in bilateral stimulation of the subthalamic nucleus (stn) and internal globus pallidus (gpi) to treat parkinsons disease, including unilateral thalamic stimulation of the ventral intermediate nucleus (vim) including the thalamus, to control tremors.The dbs ipg and lead extensions were discarded 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 implant pain and infection are known inherent risks of implanting an ipg and lead extensions as part of a system to deliver dbs.
Event or Problem Description
It was reported that the patient implanted with a deep brain stimulation (dbs) to treat pain, experienced pain localized at the implantable pulse generator (ipg) chest incision site.Pain medication was administered; however, the symptoms persisted.The patient subsequently underwent removal of the ipg and lead extensions prior to completion of the procedure.In the physicians opinion, the infection was procedure-related and associated with the incision.Device analysis was not performed, as the components were discarded by the facility.The patient was treated with antibiotics and recovered well postoperatively.

• 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: 24780764
• Report Number: 3006630150-2026-02046
• Device Sequence Number: 20366878
• Product Code: MHY
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)271208(10)813622
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 813622
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 12/08/2025
• 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: 28 YR
• Patient Sex: Female