BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3032370 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-02436
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 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 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 STOPPED CHARGING HER IPG OVER A YEAR AGO AND HER IPG IS NO LONGER ABLE TO COMMUNICATE. THE SJM REP CONFIRMED THE DEVICE'S INABILITY TO COMMUNICATE WITH EXTERNAL DEVICES. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130310 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 86639

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR IMPLANT DATE:| SCS LEAD: MODEL 3214