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

Model Number	DB-1232
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Dyskinesia (2363)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed three good faith efforts to obtain the information.Because the product serial number is unknown at this time, we are unable to provide the complete unique identifier (udi) number and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an undesired sensation of overstimulation resulting in excessive movement of the arms and legs.The stimulation was turned off with the remote control (rc) however, the sensation remained.Therefore, the patient was admitted to the hospital where stimulation was turned off with a clinician programmer (cp) and the undesired sensations ceased.The patient was discharged from the hospital on the same day.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed three good faith efforts to obtain the information.Because the product serial number is unknown at this time, we are unable to provide the complete unique identifier (udi) number and other product specific information.If additional details become available, a supplemental report will be submitted.Additional information provided in block d6a: implant date.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an undesired sensation of overstimulation resulting in excessive movement of the arms and legs.The stimulation was turned off with the remote control (rc) however, the sensation remained.Therefore, the patient was admitted to the hospital where stimulation was turned off with a clinician programmer (cp) and the undesired sensations ceased.The patient was discharged from the hospital on the same day.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an undesired sensation of overstimulation resulting in excessive movement of the arms and legs.The stimulation was turned off with the remote control (rc) however, the sensation remained.Therefore, the patient was admitted to the hospital where stimulation was turned off with a clinician programmer (cp) and the undesired sensations ceased.The patient was discharged from the hospital on the same day.

• Brand Name: VERCISE GENUS?
• 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: 23873799
• Report Number: 3006630150-2025-11610
• Device Sequence Number: 5571078
• Product Code: NHL
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)230113(10)502533
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

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: 01/13/2023
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 502533
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 01/28/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/29/2026; 02/20/2026
• Date Device Manufactured: 01/13/2021
• 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
• Patient Sex: Unknown