BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50CM IMPLANT LEAD KIT, SLIM TIP

    MDR report key: 7839006 · Received August 31, 2018

    Report

    Report Number
    1627487-2018-08282
    Event Type
    Injury
    Date Received
    August 31, 2018
    Report Date
    August 31, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    UDI-DI
    05415067025531
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. THE MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    CORRECTED PMA/510(K): P150004.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT LOST EFFECTIVE COVERAGE DUE TO THE L3 DRG LEAD HAD MIGRATED. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE LEAD WAS REPLACED WITH A NEW ONE RESTORING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678720 50CM IMPLANT LEAD KIT, SLIM TIP DRG LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN10450-50A AB2097 05415067025531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL MN10200, DRG INS| MODEL MN10450-AB2097