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

Model Number	DB-1408
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event - approximated based on the date that the manufacturer became aware of the event.Exact event date is unknown.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a shocking sensation in her back that went down the left leg during the anesthesia spinal tap portion of a non-bsc device related hip replacement procedure.The patient was hospitalized due to the shocking pain.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a shocking sensation in her back that went down the left leg during the anesthesia spinal tap portion of a non-bsc device related hip replacement procedure.The patient was hospitalized due to the shocking pain.Additional information was received that indicated after interrogation of the dbs system there was no evidence found that the device caused the shocking pain or hospitalization.
Additional Manufacturer Narrative
Block b3: date of event - approximated based on the date that the manufacturer became aware of the event.Exact event date is unknown.

• 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: 23783899
• Report Number: 3006630150-2025-11364
• Device Sequence Number: 14734828
• Product Code: NHL
• UDI-Device Identifier: 08714729989752
• UDI-Public: (01)08714729989752(17)230208(10)202740
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/08/2023
• Device Model Number: DB-1408
• Device Catalogue Number: DB-1408
• Device Lot Number: 202740
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/20/2026
• Date Device Manufactured: 02/08/2021
• 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 Age: 74 YR
• Patient Sex: Female