BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4143159 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-12646
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD ADVISORIES: 1627487-12192011-003-R AND 1627487-07262012-002-R. THESE IPG SERIAL NUMBERS WERE INCLUDED IN FIELD ADVISORIES. 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#: 1627487-2014-12647. NOTE THE PATIENT RECEIVED TWO LEAD FROM THE SAME LOT. IT WAS REPORTED THE PATIENT HAS LOST OVER 70 POUNDS. THE IPG IS NOW PROTRUDING CAUSING THE AREA TO BE UNCOMFORTABLE AND IT GETS CAUGHT ON HIS CLOTHING. THE PATIENT ALSO REPORTED THE STIMULATION IS CAUSING IRRITATION THAT LASTS FOR UP TO TWO WEEKS FOLLOWING USE OF THE STIMULATOR. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590918 EON MINI SCS IPG GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3788 2926148

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT:| SCS ANCHORS: MODEL 1194 (2)