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

Model Number	DB-1232
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an infection near the right chest over the implantable pulse generator (ipg).The patient underwent a revision procedure where the full dbs system was explanted.The patient was administered antibiotics and was doing well postoperatively.The explanted devices were disposed by the facility and were not returned.A culture was taken but the results were not available.
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: 5003317, udi: (b)(4).Product family: dbs-linear leads, upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5004325 udi: (b)(4).Product family: dbs-extension, upn: m365db3216950, model: db-3216-95, serial: (b)(6), batch: 5001118, udi: (b)(4).Product family: dbs-extension, upn: m365db3216950, model: db-3216-95, serial: (b)(6), batch: 5001125, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600-c, serial: na, batch: 36866657, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600-c, serial: na, batch: 36686668, udi: (b)(4).
Additional Manufacturer Narrative
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.Physical analysis could not be completed in our laboratory, as the devices were disposed by the medical facility and were not returned.A labelling review was performed, and it did not reveal any anomalies as it states, infection is a known risk with the use of deep brain stimulation (dbs).Additionally, labeling states that the boston scientific dbs system is indicated for use in the following: bilateral stimulation of the subthalamic nucleus (stn) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa responsive parkinsons disease (pd) that are not adequately controlled with medication.Bilateral stimulation of the internal globus pallidus (gpi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa responsive parkinsons disease (pd) that are not adequately controlled with medication.Unilateral thalamic stimulation of the ventral intermediate nucleus (vim) is indicated for the suppression of tremor in the upper extremity.The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.Bilateral stimulation of the ventral intermediate nucleus (vim) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.The devices were not returned as they were disposed by the medical facility.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).Additionally, it was reported that the dbs system was implanted for dystonia, which is not listed as an approved indication for use of the dbs system and is considered an intentional off label, unapproved, or contraindicated use.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an infection near the right chest over the implantable pulse generator (ipg).The patient underwent a revision procedure where the full dbs system was explanted.The patient was administered antibiotics and was doing well postoperatively.The explanted devices were disposed by the facility and were not returned.A culture was taken but the results were not available.

• 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: 24405862
• Report Number: 3006630150-2026-01036
• Device Sequence Number: 9905644
• Product Code: NHL
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)270622(10)796775
• 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: 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,Followup
• Report Date (Section B): 04/13/2026

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: 796775
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/13/2026
• Date Device Manufactured: 06/22/2025
• 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: 11 YR
• Patient Sex: Male