BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON PATIENT PROGRAMMER

    MDR report key: 3123946 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-01545
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 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

    IT WAS REPORTED THE PT'S BUTTONS ON THE SCS PROGRAMMER ARE STICKING. A REPLACEMENT SCS PROGRAMMER WAS SENT TO THE PT TO RESOLVE THE ISSUE. FOLLOW UP INFO IDENTIFIED THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219060 EON PATIENT PROGRAMMER SCS PROGRAMMER LGW ST. JUDE MEDICAL - NEUROMODULATION 3851 40316

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3716| IMPLANTED:| SCS LEAD: MODEL 3245