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); Bruise/Contusion (1754); Erythema (1840); Pocket Erosion (2013); Skin Inflammation/ Irritation (4545); Implant Pain (4561)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient developed an infection, with redness, bruising and pain at the implantable pulse generator (ipg) site of the deep brain stimulation (dbs) system.The patient underwent an explant procedure in which the ipg was explanted, the area was washed out with saline infused antibiotics and is undergoing treatment to resolve the infection.Cultures were taken and were positive for staphylococcus aureus infection.The patient was discharged and is recovering well.The device will not be returned as it was disposed of by the facility.
Additional Manufacturer Narrative
Block d2b pro code (product code): nhl, pjs.
Event or Problem Description
It was reported that patient developed an infection, with redness, bruising and pain at the implantable pulse generator (ipg) site of the deep brain stimulation (dbs) system, it was also noted that the skin appeared to be frail.The patient underwent an explant procedure in which the ipg was explanted, the area was washed out with saline infused antibiotics and is undergoing treatment to resolve the infection.Cultures were taken and were positive for staphylococcus aureus infection.The patient was discharged and is recovering well.The device will not be returned as it was disposed of by the facility.It was additionally reported that that left lead extension was explanted during this procedure.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes that the cause of the patient experiencing an infection and undergoing a procedure in which the ipg was explanted was confirmed based on record review, the device was not returned as it was discarded by the facility.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 device was 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.Based on all available information, engineers are able to confirm the root cause of the event.The device was not returned as such physical analysis was not 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, and the conclusion is known inherent risk of device.
Event or Problem Description
It was reported that patient developed an infection, with redness, bruising and pain at the implantable pulse generator (ipg) site of the deep brain stimulation (dbs) system, it was also noted that the skin appeared to be frail.The patient underwent an explant procedure in which the ipg was explanted, the area was washed out with saline infused antibiotics and is undergoing treatment to resolve the infection.Cultures were taken and were positive for staphylococcus aureus infection.The patient was discharged and is recovering well.The device will not be returned as it was disposed of by the facility.It was additionally reported that that left lead extension was explanted during this procedure.Additional information was received that the patient had additional symptoms of skin irritation over the ipg and that there was erosion of the ipg.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes that the cause of the patient experiencing an infection and undergoing a procedure in which the ipg was explanted was confirmed based on record review, the device was not returned as it was discarded by the facility.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 device was 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, swelling or bruising of the muscles or skin in the area of the implant 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 device was not returned as such physical analysis was not 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, and the conclusion is 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: 24341206
• Report Number: 3006630150-2026-00901
• Device Sequence Number: 4770837
• Product Code: MHY
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup,Followup
• Report Date (Section B): 07/10/2026

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: 796770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 04/21/2026; 06/15/2026
• Initial Report FDA Received Date: 02/14/2026
• Supplement Report FDA Received Date: 04/03/2026; 05/19/2026; 07/10/2026
• 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: 71 YR
• Patient Sex: Male
• Patient Race: White