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

Model Number	DB-1110-C
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Charging Problem (2892)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a deep brain stimulation (dbs) patient was taken to the emergency department due to worsening dystonia symptoms believed to be associated with inadequate stimulation.Investigation revealed that the implantable pulse generator (ipg) had not been charged properly because the patient was not using the charging system correctly.Following assistance with the charging process, the device was evaluated and found to be functioning as intended, with adequate battery status and normal impedance measurements.The patients symptoms subsequently returned to baseline, and the patient was discharged approximately one hour later.Further information indicated that the patient had recently lost her hearing aids and was unable to hear the charger beep notifications, which contributed to the improper charging of the ipg.
Additional Manufacturer Narrative
Block d.2b; additional applicable product code: pjs, mhy.

• Brand Name: Vercise?
• Common Device Name: stimulator, electrical, implanted, for parkinsonian symptoms
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50159969
• Report Number: 3006630150-2026-05631
• Device Sequence Number: 9278396
• Product Code: NHL
• UDI-Device Identifier: 08714729820758
• UDI-Public: (01)08714729820758(17)200122(10)21605199
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 01/22/2020
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 21605199
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 01/22/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female