BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON

    MDR report key: 3770031 · Received January 28, 2014

    Report

    Report Number
    1627487-2014-05088
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    December 9, 2013
    Report Date
    January 7, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PT'S IPG CAN NO LONGER HOLD A CHARGE. AN SJM REPRESENTATIVE MET WITH THE PT AND CONFIRMED THAT THE IPG IS INOPERABLE. IT WAS ALSO REPORTED THE PT HAS NOT USED HER SCS SYSTEM IN SOME TIME. AS A RESULT, THE PT PLANS TO UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61874 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 3152659

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| SCS LEADS: MODEL 3146 (X2)| IMPLANTED:| SCS LEDS: MODEL 3166 (X2)