BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 1043423 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33224
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 6, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD DXY CARDIAC PACEMAKERS, INC 4269 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention THE DEVICE 6936 TAV201 WAS USED DURING THE EVENT.| THE DEVICE 7121/AHD125 WAS IMPLANTED 29-JAN-2008| THE DEVICE 6933/TAT106 WAS IMPLANTED 02-JUL-1999| THE DEVICE 4269/269303 WAS IMPLANTED 15-APR-1997