BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 11961715 · Received June 8, 2021

    Report

    Report Number
    3006630150-2021-02743
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    October 4, 2019
    Report Date
    June 8, 2021
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(4). BATCH: 7061102.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED FEELING A TUGGING SENSATION FROM THE EXTENSION WIRES, THEREFORE, HE UNDERWENT A REVISION PROCEDURE WHEREIN THE PHYSICIAN TUNNELED TWO NEW EXTENSION WIRES AND REMOVED THE OLD ONES. THE OLD EXTENSION WIRES WERE DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED. THE PATIENT REPORTED THAT HE NO LONGER FELT THE TUGGING SENSATION AND WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857254 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7057077 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention