BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4212830 · Received October 24, 2014

    Report

    Report Number
    1627487-2014-06305
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    T WAS REPORTED THE PATIENT IS NOT RECEIVING STIMULATION. THE PATIENT HAS NOT CHARGED HER SCS IPG FOR TWO YEARS. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678836 EON MINI GZB ST. JUDE MEDICAL NEUROMODULATION SYSTEMS 3788 3258476

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2),| IMPLANT DATE:| SCS LEAD, MODEL 3186 (2),