BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2820503 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-02603
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    April 1, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL #: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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 WAS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HIS IPG AND EXTERNAL DEVICES. THE PT STATED HE DOES NOT USE THE SYSTEM VERY OFTEN AND LAST CHARGED IN (B)(6) 2012. REPLACEMENT EXTERNAL DEVICES WERE UNABLE TO RESOLVE THE ISSUE. IT WAS REPORTED THE PT WILL BE REFERRED FOR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2769047

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR SCS LEAD: MODEL 3186(2)| IMPLANT: