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); Purulent Discharge (1812); Erythema (1840); Swelling/ Edema (4577)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an infection at the burr hole cover incision site and the implantable pulse generator (ipg) chest incision site.The patient experienced symptoms of swelling, redness, and purulent discharge due to the infection.The patient underwent a revision procedure where the full dbs system was explanted.The patient was administered antibiotics and was doing well postoperatively.There was a culture taken but the results were not released by the hospital.The explanted devices were retained by the hospital and were not returned.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5002066, udi: (b)(4).Product family: dbs-linear leads, upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5002878, udi: (b)(4).Product family: dbs-extension, upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5001615, udi: (b)(4).Product family: dbs-extension, upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5002298, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600-c, serial: na, batch: 35867125, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600-c, serial: na, batch: 36076472, udi: (b)(4).
Additional Manufacturer Narrative
Device technical analysis: the devices were not returned as they were retained by the hospital.As such, physical analysis has not been conducted in our laboratory.Device history record review: a review of the manufacturing records associated with these devices indicated that they were successfully processed according to requirements.The 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.Labeling review: a labelling review was performed, and it did not reveal any anomalies as it states infection, implant site complications such as poor healing, redness, swelling, inflammation and wound reopening are known risks with the use of deep brain stimulation (dbs).Investigation conclusion: the devices were not returned as they were retained by the hospital.As such, physical analysis has not been conducted in our laboratory.However, a labeling review was conducted.This review determined the reported event of infection is a known risk associated with the use of deep brain stimulation (dbs) as documented in the instructions for use (ifu).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an infection at the burr hole cover incision site and the implantable pulse generator (ipg) chest incision site.The patient experienced symptoms of swelling, redness, and purulent discharge due to the infection.The patient underwent a revision procedure where the full dbs system was explanted.The patient was administered antibiotics and was doing well postoperatively.There was a culture taken but the results were not released by the hospital.The explanted devices were retained by the hospital and were not returned.

• 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: 24367755
• Report Number: 3006630150-2026-00940
• Device Sequence Number: 9679202
• Product Code: NHL
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)270423(10)790945
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 790945
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 04/23/2025
• 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: 62 YR
• Patient Sex: Male