BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON

    MDR report key: 2971426 · Received February 4, 2013

    Report

    Report Number
    1627487-2013-03186
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 15, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT REPORTED SHE HAS NOT CHARGED HER SCS SYSTEM IN APPROX 3 MONTHS AND IS NOT RECEIVING STIMULATION DUE TO BEING UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER SCS IPG AND CHARGING SYSTEM. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING ATTEMPTS. ADDITIONALLY, THE PT IS TO RECEIVE A REPLACEMENT PT PROGRAMMER IN ORDER TO ASSESS WHETHER THE PROGRAMMER IS ABLE TO ESTABLISH COMMUNICATION WITH THE SCS IPG OR NOT, THE PT LOST HER ORIGINAL PROGRAMMER. F/U IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47335 EON SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3716 118941

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention