BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3925744 · Received June 13, 2014

    Report

    Report Number
    1627487-2014-02428
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    CORRECTION/REMOVAL NUMBER: 1627487-07262012-002R. 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 COMPLAINED HER PAIN HAS INCREASED AND SHE DOES NOT FEEL HER SCS STIMULATION. TROUBLESHOOTING OF THE ISSUE REVEALED THE PT'S SCS IPG DOES NOT COMMUNICATE WITH EXTERNAL DEVICES. IN ADDITION, THE PT PROGRAMMER DISPLAYS A COMMUNICATION ERROR. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351276 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2929923

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR SCS LEAD: MODEL 3186 (X2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (X2)| IMPLANT DATE: