BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012242 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-03355
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    June 1, 2012
    Report Date
    February 19, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING#: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 2. REFERENCE MFR REPORT: 1627487-2013-03356. THE PATIENT HAS A PERIPHERAL AND THORACIC SCS SYSTEM. THE THORACIC SYSTEM IS BEING REPORTED. IT WAS REPORTED THE PATIENT IS NO LONGER RECEIVING STIMULATION DUE TO HER SCS IPG NO LONGER FUNCTIONING. A SJM REP CONFIRMED THE ISSUE. IT WAS ALSO REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION WHEN THE SCS IPG WAS FUNCTIONAL. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104473 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 172444

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention