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

Model Number	DB-1110-C
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	06/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient was charging the implantable pulse generator (ipg) when, within seconds of placing the charger over the ipg, the charging complete tone was emitted.Based on this indication, the patient discontinued charging; however, stimulation ceased immediately, resulting in the onset of symptoms.Consequently, the patient presented to the clinic on an urgent basis for evaluation.During the assessment, stimulation could only be maintained while the charger remained positioned over the ipg.The charger continuously emitted an audible tone indicating that charging was in progress.Further troubleshooting was performed, including the use of the hospital's charger; however, the issue persisted.In addition, attempts to establish communication with the ipg using both the programmer and the controller were unsuccessful.Based on the clinical findings and device behavior, it was suspected that the ipg battery had been adversely affected by an external factor.Therefore, the planned ipg replacement procedure was expedited and performed earlier than originally scheduled.

• 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 Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25864046
• Report Number: 3006630150-2026-05051
• Device Sequence Number: 20216839
• Product Code: NHL
• UDI-Device Identifier: 08714729820758
• UDI-Public: (01)08714729820758
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

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 Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• 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: 06/23/2026
• Initial Report FDA Received Date: 07/17/2026
• 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; Hospitalization
• Patient Sex: Unknown