BEUDAMED
    FDA Adverse Event Death Summary report: N

    NBIH BIPOLAR PACING ELECTRODE CATHETER

    MDR report key: 1156904 · Received September 10, 2008

    Report

    Report Number
    1222791-2008-00006
    Event Type
    Death
    Date Received
    September 10, 2008
    Report Date
    August 11, 2008
    Manufacturer
    C.R. BARD, INC. (BEP)
    Product Code
    LDF
    PMA / PMN Number
    K800298
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT BEING RETURNED FOR EVAL. SUMMARY: THE RESULT OF THE INVESTIGATION WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVAL. THE PRODUCT WAS 100% ELECTRICAL TESTED AT MPA123 DURING MANUFACTURING AND 100% ELECTRICAL INSPECTED AND TESTED, AND SAMPLED FOR CURVE, PRINT, ELECTRODE SPACING AND PROCESS DOCUMENTATION AT QC. ROOT CAUSE: UNK. CORRECTIVE ACTION: NO CORRECTIVE ACTION. NO SAMPLE RETURNED. THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT THERE WAS A PERFORATION OF THE MYOCARDIUM DURING THE PLACING OF THE CATHETER. THE DEVICE IS NOT BEING RETURNED FOR OUR EVAL, AND THE PT HAS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBIH BIPOLAR PACING ELECTRODE CATHETER LDF C.R. BARD, INC. (BEP)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death