BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4112910 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-08283
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    O010032
    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'S SCS IPG WILL NOT COMMUNICATE WITH EXTERNAL DEVICES, AND THE PATIENT'S PROGRAMMER DISPLAYS AN ERROR CODE. AS A RESULT,T HE PATIENT LOST SCS SYSTEM STIMULATION ON (B)(6) 2014. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE IPG IS INOPERABLE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577223 EON MINI SCS IPG GZB ST. JUDE MEDICAL NEUROMODULATION 3788 3772670

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR IMPLANT DATE:| SCS EXTENSION, MOEDE: 3386 (X2)| SCS LEAD, MODEL: 3186 (X2)| IMPLANT DATE: