BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIPOLAR TINED

    MDR report key: 1041437 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32105
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 3, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIPOLAR TINED IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 477-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention THE DEVICE 253-/18637 WAS IMPLANTED 21-SEP-1981| THE DEVICE 294-/006445 WAS IMPLANTED| THE DEVICE 294-/06445 WAS IMPLANTED 10-JAN-1997| THE DEVICE 432-/66061R WAS IMPLANTED 10-JAN-1997