BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2903233 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-05007
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 HAD LOST STIMULATION, AND THE CHARGER/PROGRAMMER COULD NO LONGER COMMUNICATE WITH THE IPG. THE PT WAS ADMITTED TO THE HOSPITAL (FOR AN ISSUE UNRELATED TO THE SCS SYSTEM) AND DID NOT RECHARGE THE IPG FOR 4 MONTHS. THE PT ALSO PASSED THROUGH AN AIRPORT SCANNER BACK IN (B)(6) 2012. AN SJM REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE ISSUE WITH A DIFFERENT CHARGER, BUT WAS UNSUCCESSFUL, AS A RESULT, THE PT'S IPG WAS EXPLANTED AND REPLACED (WITH A DIFFERENT MODEL). STIMULATION WAS REGAINED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3166349

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R SCS LEAD: MODEL 3186| IMPLANTED: