BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2903206 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-00004
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THE PATIENT'S ((B)(6)) IPG WAS EXPLANTED AND REPLACED DUE TO AN INCREASED RECHARGE BURDEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331 EON MINI SCS IPG LGW ST. JUDE MEDICAL -NEUROMODULATION DIV 3788 3254426

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention