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

Model Number	DB-1232
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Hematoma (1884); Swelling/ Edema (4577)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3 date of event approximated based on the date the manufacturer became aware of the event.Section d2b additional pro codes, nhl, pjs.With the available information in the absence of the implantable pulse generator (ipg) and lead extension products being return, boston scientific concludes that the reported event of concentration of blood, swelling and suspected infection around the ipg implant site could not be established.A review of the manufacturing documentation for the deep brain stimulation ipg and lead extensions revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, labeling states that implant site complications such as pain, poor healing, redness, warmth, swelling and infection whether these problems require device removal and/or replacement are known risk with the use of deep brain stimulation.Based on all available information in the absence of products being returned, engineers concluded that the inadequate therapy could not be confirmed.Therefore, engineers concluded and identified probable cause is, cause not established.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a concentration of blood, swelling and suspected infection around the implantable pulse generator (ipg) and lead extension implant site.In the physicians opinion the patients symptoms were not device or procedure related, however indications on the potential cause were not provided.The patient underwent a procedure wherein the ipg and lead extensions were removed before completing the procedure.Analysis of the devices was performed as they were disposed by the facility.The patient did 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: 25283686
• Report Number: 3006630150-2026-03500
• Device Sequence Number: 13181121
• Product Code: MHY
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)231104(10)517851
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 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
• Report Date (Section B): 05/26/2026

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 Expiration Date: 11/04/2023
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 517851
• 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: 05/01/2026
• Initial Report FDA Received Date: 05/26/2026
• Date Device Manufactured: 11/04/2021
• 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: 84 YR
• Patient Sex: Male