BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2780306 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-11438
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    June 29, 2012
    Report Date
    September 13, 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 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: 1627487-2012-11439. THE DEVICES WERE RECEIVED AT THE SJM FACILITY. THE PHYSICIAN'S OFFICE WAS CONTACTED, AND IT WAS REPORTED THE PT FELT THE SCS SYSTEM WAS NO LONGER PROVIDING COVERAGE OF HER PAINFUL AREAS. IT WAS REPORTED THE PT DID NOT WANT TO ATTEMPT REPROGRAMMING AND THE SCS SYSTEM WAS EXPLANTED. THE PT HAD TWO LEADS WITH THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3126730

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: