BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2871486 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-11765
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    February 1, 2011
    Report Date
    November 12, 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 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-11766. THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PATIENT HAD FALLEN AFTER IMPLANT, AND HAD NOT FELT LIKE SHE WAS RECEIVING EFFECTIVE STIMULATION. IT WAS REPORTED THE PHYSICIAN WAS SCHEDULED TO EXPLANT THE SCS SYSTEM AT THE PATIENT'S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3194890

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention IMPLANT DATE:| SCS ANCHOR, MODEL 1194 (2)