BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3101991 · Received May 6, 2013

    Report

    Report Number
    1627487-2013-03598
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 14, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2013-03599. IT WAS REPORTED, THE PATIENT EXPERIENCED SHOCKING FROM HER SCS SYSTEM. SUBSEQUENTLY, THE PATIENT WENT TO THE ER AND WAS ADMITTED TO THE HOSPITAL. IT IS UNKNOWN WHETHER SYSTEM STIMULATION WAS ON OR OFF WHEN THE EVENT OCCURRED. THE PATIENT'S SCS SYSTEM IS TO BE INTERROGATED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197240 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3925680

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R