BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 24990804 · Received April 24, 2026

    Report

    Report Number
    3006630150-2026-02622
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985020
    PMA / PMN Number
    P150031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-3128-55, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5003143, MODEL/CATALOG DESCRIPTION: DBS 2X8 EXTENSION 55CM STERILE KIT, UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT RECEIVED THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE ON THE REMOTE CONTROL. THE PATIENT EXPERIENCED INADEQUATE STIMULATION CAUSING THEIR PREEXISTING SYMPTOMS OF PARKINSON'S DISEASE RELATED TREMORS TO INCREASE IN THEIR RIGHT HAND. ATTEMPTS TO CONNECT AND REPROGRAM THE IPG WERE MADE BUT WERE UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IPG WAS REPLACED, IT WAS ALSO NOTED THAT DURING THE PROCEDURE THAT HIGH IMPEDANCES WERE NOTED, THE LEAD EXTENSION WAS ALSO REPLACED AND THE IMPEDANCES RESOLVED. THE PATIENT IS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568420 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1416 213522 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention