BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBRA

    MDR report key: 2993956 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-10069
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN THE USA, BUT IS SIMILAR TO A USA MARKETED/ APPROVED DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS NO LONGER FEELING STIMULATION ((B)(6)). IT WAS ALSO REPORTED THE PT WAS EXPERIENCING A WORSENING OF HER PARKINSON'S DISEASE. THE PT'S STIMULATION WAS RESTARTED AND EFFECTIVE STIMULATION WAS ACHIEVED. THE PT WAS HOSPITALIZED FOR TWO DAYS TO BE CERTAIN THAT STIMULATION WOULD NOT TURN OFF AGAIN. EFFECTIVE STIMULATION WAS MAINTAINED AND THE ISSUE IS CONSIDERED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89270 LIBRA DBS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 6644 3486483

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R