BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODMAN CO. LTD

    MDR report key: 1697741 · Received May 13, 2010

    Report

    Report Number
    2243801-2010-00007
    Event Type
    Malfunction
    Date Received
    May 13, 2010
    Date of Event
    April 12, 2010
    Report Date
    May 10, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MANUFACTURER TO BE EVALUATED. THE SAMPLE WAS CONTINUITY TESTED PER SPECIFICATION. DURING CONTINUITY TESTING, IT WAS DETERMINED THAT THE DISTAL ELECTRODE DOES NOT HAVE ANY CONDUCTIVITY. FURTHER INVESTIGATION SHOWED THAT THE DISTAL ELECTRODE WIRE WAS BROKEN AT THE 20 CM DISTANCE MARK. THIS BREAKAGE MIGHT OCCUR DURING CATHETER HANDLING, SUCH AS CARELESS REMOVAL FROM THE TRAY OR IN PREPARATION FOR THE PROCEDURE. ALL CATHETERS ARE 100% CONTINUITY TESTED DURING THE MANUFACTURING PROCESS PRIOR TO PACKAGING AND SHIPPING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED LOT. NO NON-CONFORMANCES WERE REPORTED DURING 100% INSPECTION. THERE HAVE BEEN NO OTHER REPORTS AGAINST THE REPORTED LOT NUMBER. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    REPORTS PACING FAILURE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO. LTD PACING CATHETER DYG B. BRAUN MEDICAL, INC. NA 61043887

    Patients

    Seq Age Sex Outcome Treatment
    1 Other