BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MIN

    MDR report key: 2840198 · Received November 13, 2012

    Report

    Report Number
    1627487-2012-12488
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627498-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 EXTERNAL DEVICES ARE UNABLE TO COMMUNICATE WITH THE IPG. REPORTEDLY THE PROGRAMMER DISPLAYS 'COMM ERROR 2501.' THE NEXT COURSE OF ACTION WAS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MIN SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2777973

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3219