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

Model Number	DB-1200-S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient passed away for an unknown reason.The attending physician did not have information regarding the cause of death.
Additional Manufacturer Narrative
Block d2b additional pro codes, nhl, pjs.Additional information was not provided despite good faith efforts.

• Brand Name: Vercise Gevia?
• 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 ; +1(763)292-0920
• MDR Report Key: 50057298
• Report Number: 3006630150-2026-05346
• Device Sequence Number: 18493891
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)211008(10)740523
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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 Expiration Date: 10/08/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 740523
• 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: 06/30/2026
• Initial Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 10/09/2019
• 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: Death
• Patient Age: 86 YR
• Patient Sex: Male