BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3161484 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-02768
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    October 18, 2012
    Report Date
    May 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 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. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-02769. IT WAS REPORTED THE PT'S SYSTEM WAS EXPLANTED ON (B)(6) 2012. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249025 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3504451

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: