BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3161719 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-04715
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R,
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2013-04716, 04717. IT WAS REPORTED THE PT HAD NOT RECHARGED THE IPG OR USED THE SCS SYSTEM FOR ABOUT 2 YRS. THE PT'S SON REPORTED HIS MOTHER HAD NOT UNDERSTOOD HOW TO USE THE SYSTEM, AND IT HAD NEVER RELIEVED HER PAIN. IT WAS REPORTED THE PT WOULD NOT PURSUE ADD'L INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248723 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3175244

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention