BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3963646 · Received May 16, 2014

    Report

    Report Number
    1627487-2014-05347
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    January 1, 2012
    Report Date
    April 23, 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 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT #: 1627487-2014-05348, 05349. IT WAS REPORTED THE PATIENT STOPPED RECHARGING HIS IPG AS RECOMMENDED SINCE 2012 DUE TO NOT RECEIVING ADEQUATE COVERAGE. IN TURN, THE IPG IS BELIEVED TO BE DEPLETED. THE PATIENT UNDERWENT A TRIAL PROCEDURE (DATE UNKNOWN) TO ADDRESS THE COVERAGE ISSUE. THE TRIAL WENT WELL, BUT THE PATIENT IS UNDECIDED ON MOVING FORWARD WITH SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293771 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3711607

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR SCS ANCHOR: MODEL 1192| IMPLANT DATE: