BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2831841 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-14020
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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: 1627487-2012-14021. THE PATIENT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION AND STOPPED USING HIS SCS SYSTEM A YEAR AGO. THE PATIENT HAD SEEN A NEUROSURGEON REGARDING HIS PAIN BEING WORSE AND WANTS TO USE HIS SCS SYSTEM AGAIN. HE IS EXPERIENCING SHARP PAIN IN HIS TOES AND HEEL. THE PATIENT WAS ADVISED TO ATTEMPT CHARGING HIS IPG TO DETERMINE IF IT STILL COMMUNICATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3053821

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE: