BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBRA XP

    MDR report key: 3960182 · Received July 23, 2014

    Report

    Report Number
    1627487-2014-21475
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED ONE SIDE OF THE PT'S ((B)(6)) IPG IS NOT ANCHORED AND AS A RESULT, THE IPG IS MOVING/TILTING. THIS ISSUE IS CAUSING DISCOMFORT WHEN THE PT LEANS FORWARD. SURGICAL INTERVENTION WILL TAKE PLACE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429802 LIBRA XP SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 6644 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other