BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3221781 · Received July 9, 2013

    Report

    Report Number
    1627487-2013-06583
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    February 3, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    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 A FIELD ADVISORY. 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 3. REFERENCE MFR REPORT: 1627487-2013-06584. REFERENCE MFR REPORT: 1627487-2013-06585. THE PATIENT WAS IMPLANTED WITH TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED, THE PATIENT'S SCS SYSTEM WAS REMOVED. THE REASON FOR THE EXPLANT IS UNDETERMINED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312411 EON MINI SCS IPG LGW ST. JUDE MEDICAL, NEUROMODULATION 3788 3269342

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other SCS EXTENSION: MODEL UNK| SCS ANCHOR: MODEL 1192 (X2)| IMPLANT DATE: