BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 20217870 · Received September 13, 2024

    Report

    Report Number
    3006630150-2024-06113
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    September 1, 2024
    Report Date
    September 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTERS PHONE NUMBER IS (B)(6) REPORTED HERE AS PHONE NUMBER EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7040209. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7073909. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7073153.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCE ON THE LEAD EXTENSION IN THE RIGHT BRAIN HEMISPHERE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED DUE TO THE NEED FOR MRI COMPATIBILITY. THE PATIENT WAS DOING WELL POST-OPERATIVELY. IT WAS UNKNOWN WHICH OF THE LEAD EXTENSION SERIAL NUMBERS HAD THE HIGH IMPEDANCE MEASUREMENTS. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113184 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7040212 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention