BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3113037 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-15629
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 19, 2013
    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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING #: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    TH PR REPORTED HE WAS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. THE PT INDICATED HE HAD NOT CHARGE HIS IPG FOR OVER 6 MONTHS. THE SJM REP IS TO MEET WITH THE PT AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207401 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2779275

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR SCS LEAD, MODEL 3186 (2)| IMPLANT DATE: