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

Model Number	DB-1408
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
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 - .
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent the procedure due to the implantable pulse generator (ipg) reaching end of battery life (ebl).It was further noted that the elective replacement indicator (eri) was received prior to the ebl message.The patient underwent an ipg revision procedure wherein their ipg was explanted and replaced.The device was disposed by the facility and will not be returned for analysis.The patient did not experience any stimulation issues.Postoperatively, the patient remained at baseline.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent the procedure due to the implantable pulse generator (ipg) reaching end of battery life (ebl).It was further noted that the elective replacement indicator (eri) was received prior to the ebl message.The patient underwent an ipg revision procedure wherein their ipg was explanted and replaced.The device was disposed by the facility and will not be returned for analysis.The patient did not experience any stimulation issues.Postoperatively, the patient remained at baseline.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.A labeling review did not reveal any anomalies as it states that when the implanted non-rechargeable stimulator is nearing the end of its battery life, the stimulator will enter the elective replacement mode.The elective replacement indicator (eri) will appear on the remote control and clinician programmer and that when the stimulator battery is fully depleted, the end of service (eos) indicator will be displayed on the remote control and clinician programmer, stimulation will not be available and surgery is required to replace the implanted non-rechargeable stimulator to continue providing stimulation.The reported event is a known risk with the use of deep brain stimulation (dbs).Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of: known inherent risk of device.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 - .

• 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: 24562925
• Report Number: 3006630150-2026-01398
• Device Sequence Number: 21215191
• Product Code: MHY
• UDI-Device Identifier: 08714729989752
• UDI-Public: (01)08714729989752(17)250606(10)209509
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/21/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/06/2025
• Device Model Number: DB-1408
• Device Catalogue Number: DB-1408
• Device Lot Number: 209509
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 06/07/2023
• 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: 73 YR
• Patient Sex: Female