BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792069 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-11493
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 20, 2012
    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 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-11492. IT WAS REPORTED THE PT HAD FALLEN ON THE IPG SITE, AND HIS HIP WAS BROKEN. X-RAYS WERE TAKEN WHICH SHOWED THE SCS SYSTEM TO BE INTACT. THE PT REPORTED HE WAS UNABLE TO INCREASE THE AMPLITUDE OF THE STIMULATION; THE PROGRAMMER WAS AUTO-REDUCING. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. IT WAS REPORTED THE PT WAS IN THE HOSPITAL HEALING AND THERE WOULD BE NO APPOINTMENTS SCHEDULED UNTIL THE OTHER HEALTH ISSUE WAS UNDER CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3614854

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R