BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3231015 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-11017
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS 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'S IPG HAS BEEN UNABLE TO COMMUNICATE WITH THE CHARGER. AN EXTERNAL FIELD REP ATTEMPTED TO ADDRESS THE ISSUE WITH AN LE CHARGING SYSTEM BUT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321718 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3497924

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR SCS LEADS: MODEL: 3268 (X2)| IMPLANT: