BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3961048 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-24022
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD ADVISORY: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-24021. PT RECEIVED TWO SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT HAS NOT RECHARGED HER IPG FOR TWO YEARS DUE TO NOT RECEIVING EFFECTIVE STIMULATION SINCE IMPLANT. AS A RESULT, COMMUNICATION COULD NOT BE ESTABLISHED WITH THE IPG AS THE DEVICE IS INOPERABLE. SURGICAL INTERVENTION WILL TAKE PLACE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413225 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2798819

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other