BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 4110316 · Received September 10, 2014

    Report

    Report Number
    1627487-2014-05648
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    January 1, 2013
    Report Date
    August 19, 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 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 STOPPED RECHARGING THE IPG AS RECOMMENDED DUE TO EXPERIENCING DIFFICULTY RECHARGING. IN TURN, THE IPG IS INOPERABLE. AS A RESULT, THE PT PLANS TO MEET WITH HIS DOCTOR AND AN SJM REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559835 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3789412

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR SCS LEAD: MODEL: 3228| IMPLANT: