BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110814 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02618
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    October 15, 2012
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    IT WAS REPORTED THE PT FELT A "JOLT" FROM HER SYSTEM APPROX 6 MONTHS AGO WHILE AT PHYSICAL THERAPY. SHE ALLEGEDLY TURNED OFF THE SYSTEM AND HAD NOT USED OR CHARGED THE IPG SINCE THAT TIME. SHE STATED HER IPG IS NOW UNABLE TO COMMUNICATE WITH HER EXTERNAL DEVICES. F/U INDICATED THE PT HAD A CONSULT WITH HER PHYSICIAN, AND SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204817 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention