BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4093629 · Received September 4, 2014

    Report

    Report Number
    1627487-2014-01572
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    June 1, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 LAST RECHARGED THE SCS SYSTEM 2 MONTHS AGO; HOWEVER STIMULATION CEASED APPROXIMATELY MONTH AGO. SUBSEQUENTLY, THE IPG IS NOT COMMUNICATING WITH ANY EXTERNAL DEVICES. AN ALTERNATE CHARGER AND PATIENT PROGRAMMER WERE ATTEMPTED TO NO AVAIL. SURGICAL INTERVENTION MAY BE UNDERTAKEN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542160 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4157664

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)