BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052272 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-02470
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFO 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 UNABLE TO ESTABLISH COMMUNICATION BETWEEN HIS IPG AND EXTERNAL DEVICES. REPLACEMENT EXTERNAL DEVICES WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. THE PT REPORTED HE LAST CHARGED ABOUT 3-4 MONTHS AGO, AND HE LOST STIMULATION APPROX 1 MONTH AGO. F/U INDICATED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137791 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3249807

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention