BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON

    MDR report key: 2943337 · Received January 23, 2013

    Report

    Report Number
    1627487-2013-01091
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-1090. IT WAS REPORTED THE PATIENT IS UNABLE TO TURN STIMULATION ON DUE TO AUTO-REDUCING. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND LEAD DIAGNOSTICS WERE NORMAL AND PROGRAMMING WAS ABLE TO PROVIDE EFFECTIVE STIMULATION, BUT ISSUE CONTINUED. A REPLACEMENT PATIENT PROGRAMMER WAS UNABLE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33179 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 R45327A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention