BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODMAN CO LTD

    MDR report key: 1461895 · Received May 11, 2009

    Report

    Report Number
    2243801-2009-00002
    Event Type
    Malfunction
    Date Received
    May 11, 2009
    Date of Event
    April 2, 2009
    Report Date
    April 30, 2009
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. THE HOUSE RETAIN SAMPLE FOR THE REPORTED LOT WAS CONTINUITY TESTED PER SPECIFICATION AND WAS NOTED TO PASS ALL TESTING ON BOTH ELECTRODES. THERE WAS NO LOSS IN CONTINUITY THAT COULD RESULT IN PACING FAILURE. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVAL COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT OF PRODUCT.

    Description of Event or Problem · 1

    REPORTS HAD A PACING FAILURE WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO LTD PACING CATHETER DYG B. BRAUN MEDICAL, INC. NA 60977444

    Patients

    Seq Age Sex Outcome Treatment
    1 Other