BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2833885 · Received November 5, 2012

    Report

    Report Number
    1627487-2012-12438
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFO 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 1 OF 4. REFERENCE MFR # 1627487-2012-12439, REFERENCE MFR # 1627487-2012-12440, REFERENCE MFR # 1627487-2012-12441. IT WAS REPORTED THE PT HAS NOT USED THE SYSTEM FOR GREATER THAN TWO YEARS. THE SJM REP INTERROGATED THE SYSTEM AND ALL LEADS HAVE INVALID IMPEDANCE. REPORTEDLY THE PHYSICIAN ORDERED X-RAYS. THE NEXT COURSE OF ACTION WAS UNDETERMINED. NOTE THE PT HAS TWO LEADS FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2758861

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS ANCHOR: MODEL 1194(2)| IMPLANT DATE: