BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRIAL J SELUTE PICOTIP

    MDR report key: 1042243 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34394
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIAL J SELUTE PICOTIP IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4063 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other THE DEVICE 1230/233031 WAS IMPLANTED 09-FEB-2000| THE DEVICE 4034/212224 WAS IMPLANTED 09-FEB-2000| THE DEVICE UNKN/UNKNOW WAS IMPLANTED 08-JUL-1999