BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON

    MDR report key: 3963596 · Received May 30, 2014

    Report

    Report Number
    1627487-2014-05403
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PATIENT PLANS TO UNDERGO SURGICAL INTERVENTION DUE TO FREQUENT CHARGING, AND LOSING STIMULATION ON MULTIPLE OCCASIONS AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319979 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 3479556

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: