BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3961049 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-08116
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 HAD NO STIMULATION FROM HER SCS SYS BEGINNING ON (B)(6) 2014. THE PT WAS INSTRUCTED TO ATTEMPT CHARGING AS THE PT HADN'T CHARGED IN THREE WEEKS, BUT COMMUNICATION COULD NOT BE ESTABLISHED WITH THE PT'S EXTERNAL DEVICES. AN SJM REP MET WITH THE PT AND CONFIRMED COMMUNICATION ERROR. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413316 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3463357

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SCS LEAD, MODEL 3219| IMPLANT DATE: