BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBRA

    MDR report key: 2842058 · Received November 12, 2012

    Report

    Report Number
    1627487-2012-06734
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    October 7, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 PATIENT (B)(6) RECEIVED A LOW BATTERY WARNING. AS A RESULT, THE PATIENT'S IPG WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBRA DBS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 6644 3209164

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention