BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50CM IMPLANT LEAD KIT, SLIM TIP

    MDR report key: 8592092 · Received May 8, 2019

    Report

    Report Number
    1627487-2019-05403
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    April 23, 2019
    Report Date
    May 8, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    UDI-DI
    05415067025531
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE 1 OF 2, MFG REPORT REFERENCE: 1627487-2019-05404. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPLACE THE LEADS. EFFECTIVE THERAPY WAS RESTORED POST OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383310 50CM IMPLANT LEAD KIT, SLIM TIP DRG LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN10450-50A AB2097 05415067025531

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other MODEL MN10450-50A, DRG LEAD