BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2881043 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-06922
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    December 19, 2011
    Report Date
    November 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 6. REFERENCE MFR REPORT: 1627487-2012-06923, REFERENCE MFR REPORT: 1627487-2012-06924, REFERENCE MFR REPORT: 1627487-2012-06925, REFERENCE MFR REPORT: 1627487-2012-06926, REFERENCE MFR REPORT: 1627487-2012-06927. ON (B)(6) 2012, AN SJM REP WAS GIVEN THE PT'S SCS SYSTEM IN A BAG. HE WAS INFORMED, THE PT WAS EXPLANTED ON (B)(6) 2011. THE REASON FOR EXPLANT REMAINS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 66916

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention