BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 24901361 · Received April 16, 2026

    Report

    Report Number
    3006630150-2026-02401
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    January 1, 2025
    Report Date
    April 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATELY JANUARY 2025. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: NM-3138-55 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7112866 MODEL/CATALOG DESCRIPTION: 55CM 8 CONTACT EXTENSION UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: NM-3138-55 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7112999 MODEL/CATALOG DESCRIPTION: 55CM 8 CONTACT EXTENSION UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HIGH IMPEDANCE READINGS OBSERVED ON A COUPLE OF ELECTRODES. DURING THE PROCEDURE, THE LEAD EXTENSIONS WERE REMOVED FROM THE EXISTING IMPLANTABLE PULSE GENERATOR (IPG), CLEANED THOROUGHLY, AND THEN REINSERTED INTO THE IPG HOWEVER, THE IMPEDANCE ISSUE PERSISTED. THE IPG WAS THEN REPLACED DURING THE PROCEDURE AND ONCE AGAIN THE IMPEDANCE ISSUE DID NOT IMPROVE. THEREFORE, THE LEAD EXTENSIONS WERE ALSO REPLACED WHICH SUCCESSFULLY RESOLVED THE IMPEDANCE ISSUE. THE PHYSICIAN ASSESSED THAT THE EXISTING LEAD EXTENSIONS WERE CURVED MORE MEDIALLY THAN USUAL IN THE CERVICAL REGION RESULTING IN A DEGREE OF TENSION THAT MAY HAVE BEEN APPLIED CAUSING THE IMPEDANCE ABNORMALITY. THE PATIENT IS DOING WELL POSTOPERATIVELY AND THE PARKINSONS DISEASE SYMPTOMS ARE WELL CONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343370 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 575869 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1