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	Charging Problem (2892)
Health Effect - Clinical Code	Inappropriate Device Stimulation of Tissue (4928)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced difficulty charging the deep brain stimulation (dbs) implantable pulse generator (ipg).The patient stated that, after charging for approximately one hour, the battery displayed one-third charge.The patient also reported experiencing a shock-like sensation during charging.No device malfunction was confirmed, and evaluation of the charger indicated that it was functioning as expected.As part of the intervention, troubleshooting was performed and the patient was educated regarding the thermistor function and appropriate charging practices, including charging in two-hour intervals and ensuring adequate charger ventilation.The patient was also advised to consult with the treating physician regarding the reported shock-like sensation.The patient subsequently consulted with the treating provider and reported no recurrence of the sensation.At the time of the latest follow-up, the patient reported no additional charging-related issues.The patient indicated a desire for faster charging but understood the limitations of the recharge process and planned to charge more frequently to reduce charging duration.The patient was advised to contact the representative directly if any further issues occur.The ipg remains implanted, and no device was returned for analysis.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: nhl, pjs.

• 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: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50146038
• Report Number: 3006630150-2026-05600
• Device Sequence Number: 10730969
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 09/23/2026

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: 08/19/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 743917
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 08/19/2020
• 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: Other
• Patient Age: 85 YR
• Patient Sex: Male