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

Model Number	DB-1200-S
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Fall (1848); Dyskinesia (2363); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient had experienced inadequate parkinson's disease symptoms control for more than one year, particularly with respect to dyskinesia.It was also reported that the patient experiences electrical shock like sensations when stimulation is active, with the sensations radiating to the arms and legs.As a result, the patient has been unable to use the therapy consistently and has only been able to tolerate therapy during certain periods, such as overnight while sleeping.Additionally, it was reported that the patient sustained a fall approximately two years ago that resulted in a head injury.The patient was evaluated by a neurologist, and reprogramming was attempted as a troubleshooting measure; although the intervention was successful initially, after a short period of time, it was no longer effective, as dyskinesia returned shortly after the adjustment.At the time of this report, the implantable pulse generator (ipg) remains implanted.
Additional Manufacturer Narrative
B3: estimated based on gfe response from sales representative, considering the progression of the issue over the past year.D2b: additional pro code selection that applies to the indication of this device - .

• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50841053
• Report Number: 3006630150-2026-06936
• Device Sequence Number: 9949753
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 10/05/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 744322
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 10/05/2020
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male