BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3369608 · Received September 5, 2013

    Report

    Report Number
    1627487-2013-18333
    Event Type
    Malfunction
    Date Received
    September 5, 2013
    Date of Event
    August 1, 2012
    Report Date
    August 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 INFO 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 NO LONGER RECEIVING STIMULATION AND WAS UNABLE TO COMMUNICATE WITH OR CHARGE HER IPG. THE PT SUFFERED A STROKE APPROXIMATELY 1 YR AGO AND HAS NOT USED OR CHARGED HER SCS SYSTEM SINCE. THE SJM REP IS TO CONTACT THE PT AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442203 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2777973

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR IMPLANT DATE:| SCS LEAD: MODEL 3166 (2)