BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODMAN CO LTD

    MDR report key: 1478577 · Received June 26, 2009

    Report

    Report Number
    2243801-2009-00006
    Event Type
    Malfunction
    Date Received
    June 26, 2009
    Date of Event
    March 18, 2009
    Report Date
    June 11, 2009
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    DYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    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 60988639

    Patients

    Seq Age Sex Outcome Treatment
    1 Other