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

Model Number	DB-1200-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
This emdr was submitted as the regulatory assessment decision for this complaint was corrected due to a remediation effort associated with (b)(4).Block d2b: additional pro codes: nhl, pjs.Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) has passed away.No additional information was available.The cause of death was not reported.The physician for the patient provided information that the patient suffered from dementia and that was believed to have contributed to their death.They indicated the stimulator was not thought to have caused or contributed to the death.The stimulator remained implanted.
Additional Manufacturer Narrative
Block d2b: additional pro codes: nhl, pjs.Block b3: approximated based on the date the manufacturer became aware of the event.The subject device was not returned; therefore, no device evaluation was performed.A review of the available clinical information and investigation activities identified a reported adverse outcome (death).However, the information provided included only a potential contributing condition, which could not be confirmed or substantiated with objective evidence.No device malfunction or deficiency was identified based on the available information.Given the limitations of the investigation and the absence of sufficient objective evidence to establish causality, the probable cause is assessed as cause not established.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) has passed away.No additional information was available.The cause of death was not reported.The physician for the patient provided information that the patient suffered from dementia and that was believed to have contributed to their death.They indicated the stimulator was not thought to have caused or contributed to the death.The stimulator remained implanted.

• 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 ; 7632920920
• MDR Report Key: 25019493
• Report Number: 3006630150-2026-02698
• Device Sequence Number: 13336001
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)220603(10)742874
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/03/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 742874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 06/03/2020
• 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: 78 YR
• Patient Sex: Male