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	Unspecified Infection (1930); Impaired Healing (2378)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b pro code (product code): nhl, pjs additional suspect medical device components involved in the event: model number/catalog number: db-3216-55 serial number: (b)(6).Batch/lot number: 5003816 and 5003683 model/catalog description: argyle extension 55cm sterile kit unique identifier (udi) # (b)(4).
Event or Problem Description
It was reported that the patients' implantable pulse generator (ipg) incision site, on their chest, of the deep brain stimulation (dbs) did not heal adequately and developed an infection, the patient was asymptomatic.The patient was hospitalized, underwent an explant of the (ipg) and the lead extensions, cultures were taken, however, the results are unknown, and the patient was placed on antibiotics.The patient is expected to fully recover.The devices will not be returned as they were discarded by the facility.
Event or Problem Description
It was reported that the patients' implantable pulse generator (ipg) incision site, on their chest, of the deep brain stimulation (dbs) did not heal adequately and developed an infection, the patient was asymptomatic.The patient was hospitalized, underwent an explant of the (ipg) and the lead extensions, cultures were taken, however, the results are unknown, and the patient was placed on antibiotics.The patient is expected to fully recover.The devices will not be returned as they were discarded by the facility.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: db-3216-55 serial number:(b)(6) batch/lot number: 5003816 and 5003683 model/catalog description: argyle extension 55cm sterile kit unique identifier (udi) # (b)(4).With all the available information, boston scientific concludes that the cause of the patient experiencing impaired healing, an infection, being hospitalized and undergoing a procedure in which the ipg and lead extension were explanted, was confirmed based on record review.A review of the manufacturing records associated with the device indicated that it was successfully processed according to requirements.The device history review, dhr, did not identify any manufacturing process-related non-conformances, scrap, or rework performed during production that could have caused or contributed to this event.The dhr review ensures each device meets required specifications and associated testing prior to release for distribution/sale.The devices were discarded by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A labeling review was performed on the devices' instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.It states infection and implant site complications such as pain, poor healing, redness, warmth, swelling or wound reopening are a known risks with the use of deep brain stimulation.Based on all available information, engineers are able to confirm the root cause of the event.The devices were not returned as such physical analysis was conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is able to determine a probable root cause for the complaint as known inherent risk of device.

• 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: 24492425
• Report Number: 3006630150-2026-01215
• Device Sequence Number: 17397595
• Product Code: MHY
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)270814(10)801365
• 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: 2025
• 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): 04/09/2026

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: 801365
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 08/14/2025
• 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; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male