BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3202045 · Received June 27, 2013

    Report

    Report Number
    1627487-2013-05916
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 3, 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
    NE, 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 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 PT HAS LOST STIMULATION DUE TO THE CHARGER NO LONGER BEING ABLE TO COMMUNICATE WITH THE IPG. AS A RESULT, THE PT MAY UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293060 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3422911

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3228| SCS EXTENSIONS: MODEL 3382 (X2)