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

Model Number	DB-1232
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	11/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a communication error with the implantable pulse generator (ipg) and a loss of stimulation resulting in a return of their pre-existing tremor after they underwent a cardioversion.The cardioversion was performed at 200 voltages at the right shoulder above the ipg which was turned off prior to the procedure.As such, the physician assessed the cardioversion may have contributed to the communication difficulty and loss of stimulation.Therefore, the patient underwent a revision procedure during which the ipg was explanted and replaced.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Device analysis performed on the returned ipg revealed that it would not communicate with a known working remote control (rc) or clinician programmer (cp) and was unable to be charged despite multiple charging attempts.Functional testing was unable to be performed and the data logs were unable to be retrieved.The ipg was then cut open and internal electrical measurements revealed a high sleep current and lower than expected resistance, indicating a damaged application specific integrated circuit (asic) chip.This damaged asic is typical of exposure to high voltage transients and high current sources such as electrocautery.A labeling review confirmed that electrocautery or some other medical therapies or procedures may turn stimulation off or may cause permanent damage to the device if used in close proximity, as documented in the ifu.Therefore this type of damage was likely caused by an external high voltage or high current transient source such as the reported cardioversion and was an unintended use error that had likely caused or contributed to the event.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a communication error with the implantable pulse generator (ipg) and a loss of stimulation resulting in a return of their pre-existing tremor after they underwent a cardioversion.The cardioversion was performed at 200 voltage at the right shoulder above the ipg which was turned off prior to the procedure.As such, the physician assessed the cardioversion may have contributed to the communication difficulty and loss of stimulation.Therefore, the patient underwent a revision procedure during which the ipg was explanted and replaced.The patient was doing well postoperatively.

• 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: 24117407
• Report Number: 3006630150-2026-00423
• Device Sequence Number: 17609097
• Product Code: PJS
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)261205(10)777354
• 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: 2025
• Device Explanted Year: 2025
• 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): 04/29/2026

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: Health Professional
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 777354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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
• Patient Age: 73 YR
• Patient Sex: Female