BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3032817 · Received February 11, 2013

    Report

    Report Number
    1627487-2013-10107
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. CORRECTION/REMOVAL NUMBER: 1627487-12192011-003-R, 1627487-07262012-002-R. H6: RESULTS - IT WAS FOUND THAT THE IPG FAILED THE UCOD TEST DUE TO BROKEN FEED THROUGH WIRE ON CHANNEL 8. 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 2 OF 2: REFERENCE MFR. REPORT: 1627487-2012-09239.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60739 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2834055

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3341 (2)