BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3950255 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-15388
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 1, 2012
    Report Date
    May 5, 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 CORRECTION: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 WAS NO LONGER RECEIVING STIMULATION AND WAS UNABLE TO COMMUNICATE WITH OR CHARGE HER IPG. THE SJM REP MET WITH THE PT AND CONFIRMED THE ISSUE. THE PT INDICATED SHE HAD NOT CHARGED HER IPG IN OVER TWO YEARS. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376604 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2767436

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other IMPLANT DATE:| SCS LEAD, MODEL 3214,