BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3860434 · Received April 15, 2014

    Report

    Report Number
    1627487-2014-25276
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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, THE PT HAS NOT RECHARGED THE IPG AS RECOMMENDED SINCE (B)(6) 2013. AS A RESULT, THE PT IS NOT RECEIVING STIMULATION AND THE PROGRAMMER IS NOT COMMUNICATING WITH IPG. THE PT WILL DETERMINE THAT THE NEXT COURSE OF ACTION SHE WANTS TO TAKE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230769 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3463532

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194| SCS LEADS: MODEL 3186 (X2)| SCS ANCHORS: MODEL 1192 (X2)