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 Code	Impaired Healing (2378)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximation - per the patient, has had this scab on the extension site since surgery and it never healed.Block d2b: additional applicable product code: nhl.Additional suspect medical device components involved in the event: model number/catalog number: db-3216-55, serial number: (b)(6), batch/lot number: 5004712, model/catalog description: argyle extension 55cm sterile kit, unique identifier (udi) #: (b)(4).Model number/catalog number: db-3216-55, serial number: (b)(6), batch/lot number: 5005293, model/catalog description: argyle extension 55cm sterile kit, unique identifier (udi) #: (b)(4).The devices were retained by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A labeling review did not reveal any anomalies and states that the following may be potential risks associated with the use of the device: implant site complications such as pain, poor healing, redness, warmth, swelling or wound reopening and infection.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure of the implantable pulse generator (ipg) and lead extensions due to a scab at the lead extensions site that was not healing.The patient was prescribed antibiotics, and cultures were taken, but the results have not been disclosed.Postoperatively, the patient is stable.The explanted devices were retained by the facility and will not be returned to boston scientific for analysis.

• 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: 25236409
• Report Number: 3006630150-2026-03329
• Device Sequence Number: 5108973
• Product Code: MHY
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)271007(10)807918
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 807918
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 10/07/2025
• 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: 72 YR
• Patient Sex: Male