BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON MINI

    MDR report key: 3150537 · Received May 30, 2013

    Report

    Report Number
    1627487-2013-15708
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    May 27, 2012
    Report Date
    May 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    CORRECTION/REMOVAL NUMBER: 1627487-12192011-003-R. THIS SERIAL NUMBER WAS 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

    IT WAS REPORTED THE PT PASSED AWAY ON (B)(6) 2012. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237794 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2761931

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death IMPLANT DATE:| SCS LEAD, MODEL 3219