BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 20391783 · Received October 7, 2024

    Report

    Report Number
    3006630150-2024-06745
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7072225.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) SYSTEM WAS EXPLANTED DUE TO DEVICE MIGRATION. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2542291 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7075639 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention