BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2772155 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-06494
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 IS NO LONGER RECEIVING STIMULATION. THE PT HAS NOT RECHARGED OR USED THE IPG IN THREE MONTHS. IT WAS ALSO REPORTED THE CHARGER AND PROGRAMMER CAN NO LONGER COMMUNICATE WITH THE IPG. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 2893991

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS LEADS: MODEL 3186 (2)| IMPLANT: