BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE-PASS

    MDR report key: 1043421 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33222
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE-PASS IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 425-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention THE DEVICE 1290/804451 WAS IMPLANTED 25-JAN-2008| THE DEVICE 292-/112733 WAS IMPLANTED 21-JUN-2000| THE DEVICE 4088/229571 WAS IMPLANTED 25-JAN-2008| THE DEVICE 4480/490596 WAS IMPLANTED 25-JAN-2008