BEUDAMED
    FDA Adverse Event Death Summary report: N

    6F 125 COURN NBIH

    MDR report key: 625613 · Received August 11, 2005

    Report

    Report Number
    1222791-2005-00007
    Event Type
    Death
    Date Received
    August 11, 2005
    Report Date
    June 29, 2005
    Manufacturer
    C.R. BARD,INC, (BEP)
    Product Code
    LDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER PLACEMENT OF THE TEMPORARY PACING ELECTRODE ON FOUR DIFFERENT PATIENTS, THE PACING WIRE MIGRATED INTO THE PERICARDIUM. TWO PATIENTS REQUIRED SURGERY AND ONE EXPIRED (COULD HAVE BEEN BY SURGERY BUT THE FAMILY CHOSE TO KEEP THEM COMFORTABLE). ALL OTHER PATIENTS RECOVERED WITH NO LONG-TERM SEQUELAE. THE ACTUAL SAMPLES HAVE NOT BEEN RETURNED FOR EVALUATION AS THEY HAVE BEEN DISCARDED BY THE HOSPITAL. ADDITIONALLY THE HOSPITAL OPENED UNUSED INVENTORY AND INSPECTED IT. THEY COMMENTED THAT THE PACING LEAD TIP APPEARED TO HAVE A POOR ROUGH MANUFACTURED FINISH. A FURTHER COMMENT BY THE DOCTORS STATED THEY BELIEVED THAT THE ELECTRODES ARE POSSIBLY TOO RIGID AND NOT FLEXING EFFECTIVELY WHEN PUSHED AGAINST SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F 125 COURN NBIH TEMPORARY PACING ELECTRODE CATHETER LDF C.R. BARD,INC, (BEP) * GP0K4449

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death