BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4091958 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-20164
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: # 1627487-2014-20165. IT WAS REPORTED THE PT'S SCS IPG WAS REPOSITIONED DUE TO EXPERIENCING DISCOMFORT AT THE IPG SITE. DURING THE PROCEDURE THE PHYSICIAN DISCOVERED ONE OF THE PTS SCS LEAD WAS BROKEN. SUBSEQUENTLY, THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE STIMULATION WAS ESTABLISHED POST OPERATIVELY AND THE PAIN AT THE ORIGINAL IPG SITE WAS RESOLVED. THE PT HAS TWO WITH THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522480 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4478344

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE: