BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON

    MDR report key: 3060222 · Received April 11, 2013

    Report

    Report Number
    1627487-2013-02481
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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

    THE PT UNDERWENT SURGERY FOR THE IMPLANT OF A PERMANENT SCS SYSTEM. IT WAS REPORTED THE IPG FAILED TO ESTABLISH COMMUNICATION WITH THE PROGRAMMER PRIOR TO BEING IMPLANTED. THE PROGRAMMER SUCCESSFULLY COMMUNICATED WITH 2 OTHER IPGS THROUGH THE BOX. THE PHYSICIAN DECIDED TO USE A DIFFERENT MODEL IPG AND THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155168 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3818175

    Patients

    Seq Age Sex Outcome Treatment
    1