BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBRA XP

    MDR report key: 3900127 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-02367
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    March 31, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. THIS DEVICE IS NOT APPROVED FOR SALE IN THE USA, BUT IS SIMILAR TO A USA MARKETED/APPROVED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S ((B)(6)) DBS QUIKLINK CONTROLLER DISPLAYED THE "LOW BATTERY" MESSAGE. THE PT'S DBS IPG WAS REPLACED WITH A NEW ONE. THE PT REPORTED RECEIVING EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315034 LIBRA XP DBS IPG LGW ST. JUDE MEDICAL ¿ NEUROMODULATION 6644MD 3986377

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other IMPLANT DATE:| SCS EXTENSION, MODEL 6345 (X2)