BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3850301 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-23321
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    February 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-12192011-003-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 IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN THE IPG AND THE PT'S PROGRAMMER. IT WAS ALSO REPORTED THE PROGRAMMER DISPLAYS A COMMUNICATION ERROR. THE PT HAS NOT CHARGED THE IPG IN APPROXIMATELY 2 MONTHS AND THE PT IS WITHOUT STIMULATION. THE PT WILL UNDERGO SURGICAL INTERVENTION AT A FUTURE DATE AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290597 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2843105

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other SCS LEAD: MODEL 3186| IMPLANTED: