BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3060233 · Received April 11, 2013

    Report

    Report Number
    1627487-2013-02495
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 WAS UNABLE TO ESTABLISH COMMUNICATION WITH HER CHARGER OR PROGRAMMER. THE PT REPORTED SHE HAD STOPPED CHARGING SOME TIME AGO BECAUSE SHE HAD LOST HER CHARGER. IT WAS REPORTED THE PT IS LOOKING FOR A NEW PHYSICIAN TO CONSULT WITH REGARDING AN IPG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154917 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3584295

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR IMPLANTED:| IMPLANTED| SCS LEAD: MODEL 3186 (2)| SCS ANCHOR: MODEL 1192 (2)