BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3113044 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-13736
    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
    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 WAS INCLUDED IN A FIELD ADVISORY AND FIELD CORRECTION. 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

    THE PT STATED HE HAS NOT CHARGED HIS IPG FOR APPROX 4 MONTHS AND HE NO LONGER HAS STIMULATION COVERAGE. THE PT STATED HE HAD MOVED AND MISPLACED HIS CHARGING SYSTEM, SO HE WAS UNABLE TO CHARGE. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207484 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2852898

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)