BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3113033 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-03616
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    TH PT'S DAUGHTER REPORTED THE PT HAS NOT CHARGED SINCE IMPLANT AND IS NO LONGER RECEIVING STIMULATION. THE PT'S DAUGHTER ALSO REPORTED THE CHARGING SYSTEM DOES NOT POWER ON. SUBSEQUENTLY, THE PT WAS SENT A REPLACEMENT CHARGING SYSTEM AND ANTENNA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207400 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3951229

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)| IMPLANT DATE:| SCS ABCHOR, MODEL 1192 (2)