BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2903004 · Received December 26, 2012

    Report

    Report Number
    1627487-2012-11909
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    November 8, 2012
    Report Date
    December 6, 2012
    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

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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: 1627487-2012-11910. THE PT REC'D TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT FELT THE SYSTEM WAS NO LONGER HELPING. THE PT NOTIFIED THE SJM REP SHE WAS WORKING WITH A NEW PHYSICIAN, AND THE SCS SYSTEM WAS EXPLANTED. THE PT WAS ASKED IF SHE HAD TRIED REPROGRAMMING PRIOR TO THE DECISION. THE PT REPORTED SHE HAD NOT ATTEMPTED REPROGRAMMING, AND WANTED THE SYSTEM REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3203834

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention