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); Erythema (1840); Swelling/ Edema (4577)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an explant procedure where in the entire deep brain stimulation (dbs) system was explanted due to an infection.Following a non device related incident, the patient sustained a laceration to the head after nicking the extension header.The site subsequently became red and swollen.The wound developed an infection, which later extended to other components of the implanted system, including the implantable pulse generator (ipg) area.The patient was initiated on antibiotics.Cultures were obtained; however, the results were not provided.The devices were retained by the hospital and will not be returned for analysis.Postoperatively, the patient was doing well.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event d2b: additional pro code selection that applies to the indication of this device - .Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2203450.Model: db-2203-45.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db2203450.Model: db-2203-45.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Product family: dbs-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Product family: dbs-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).

• 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: 23991911
• Report Number: 3006630150-2026-00153
• Device Sequence Number: 10531122
• Product Code: MHY
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)261002(10)767284
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2025
• 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): 01/07/2026

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: 10/02/2026
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 767284
• 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: 12/09/2025
• Initial Report FDA Received Date: 01/07/2026
• Date Device Manufactured: 10/02/2024
• 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: 65 YR
• Patient Sex: Male