BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA ENTRA

    MDR report key: 1042089 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34548
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA ENTRA IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1294 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention THE DEVICE 4456/442068 WAS IMPLANTED 21-SEP-2006| THE DEVICE 4479/427632 WAS IMPLANTED 21-SEP-2006