BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3113308 · Received April 30, 2013

    Report

    Report Number
    1627487-2013-05621
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    IT WAS REPORTED THE PATIENT HAS NOT RECHARGED THE IPG AS RECOMMENDED DUE TO THE CHARGER BEING DAMAGED. AS A RESULT, THE PROGRAMMER CAN NO LONGER COMMUNICATE WITH THE IPG. THE PATIENT WAS SENT A REPLACEMENT CHARGER AND WILL MEET WITH AN SJM REPRESENTATIVE FOR TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188848 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3290655

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention IMPLANT:| SCS ANCHORS: MODEL 1194 (X2)| IMPLANT:| SCS LEADS: MODEL 3186 (2)