BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3151481 · Received June 4, 2013

    Report

    Report Number
    1627487-2013-05779
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING# 1627487-07262012-002-R. THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 THAT PT HAS NOT MAINTAINED THE IPG AS RECOMMENDED. AS A RESULT, THE CHARGER CAN NO LONGER COMMUNICATE WITH THE IPG. AN SJM REP MET WITH THE PT AND CONFIRMED THE CHARGER AND PROGRAMMER COULD NOT COMMUNICATE WITH THE IPG. THE PT HAS BEEN USING PAIN MEDICATION TO MANAGE HER PAIN. HE MAY UNDERGO SURGICAL INTERVENTION ON A LATER DATE IF THE DOCTOR FEELS IT'S IN HIS BEST INTEREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246086 EON MINI SCS IPG LGW ST. JUDE MEDICAL, NEUROMODULATION 3788 2891069

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANT: