MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise Genus?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-1432
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Dyskinesia (2363); Ambulation or Postural Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient received the end of battery life (ebl) message of the implantable pulse generator (ipg) shortly after implantation.The device remains implanted.A replacement procedure is anticipated in the future; however, no specific date has been established at this time.
Additional Manufacturer Narrative
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 received the end of battery life (ebl) message of the implantable pulse generator (ipg) shortly after implantation.The device remains implanted.A replacement procedure is anticipated in the future; however, no specific date has been established at this time.
Additional Manufacturer Narrative
The device was not returned to boston scientific for comprehensive analysis, and the available media inspection did not substantiate a battery related malfunction.A review of the implantable pulse generator (ipg) database was subsequently conducted by the technical support team.However, the database review was inconclusive and did not establish a definitive root cause for the ipg approaching end of battery life.A review of the device history record (dhr) confirmed that the device met specification prior to shipping and no manufacturing deviations were noted that could have contributed to the event reported.Therefore, in the absence of device return and analysis, the likely root cause could not be established.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 received the end of battery life (ebl) message of the implantable pulse generator (ipg) shortly after implantation.The device remains implanted.A replacement procedure is anticipated in the future; however, no specific date has been established at this time.Additional information was received stating that the dbs patient underwent the ipg replacement.The device was retained by the hospital.Postoperatively, the patient's stimulation was restored.
Additional Manufacturer Narrative
The device was not returned to boston scientific for comprehensive analysis, and the available media inspection did not substantiate a battery related malfunction.A review of the implantable pulse generator (ipg) database was subsequently conducted by the technical support team.However, the database review was inconclusive and did not establish a definitive root cause for the ipg approaching end of battery life.A review of the device history record (dhr) confirmed that the device met specification prior to shipping and no manufacturing deviations were noted that could have contributed to the event reported.Therefore, in the absence of device return and analysis, the likely root cause could not be established.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: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25129048
• Report Number: 3006630150-2026-02998
• Device Sequence Number: 15646278
• Product Code: MHY
• UDI-Device Identifier: 08714729985037
• UDI-Public: (01)08714729985037(17)271016(10)242939
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/02/2026

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 Model Number: DB-1432
• Device Catalogue Number: DB-1432
• Device Lot Number: 242939
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 04/23/2026; 05/18/2026; 06/08/2026; Not provided; 09/07/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/19/2026; 06/12/2026; 07/01/2026; 09/03/2026; 10/02/2026
• Date Device Manufactured: 10/16/2025
• 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: 59 YR
• Patient Sex: Male