BEUDAMED
    FDA Adverse Event Other Summary report: N

    GOODMAN CO. LTD

    MDR report key: 823321 · Received March 1, 2007

    Report

    Report Number
    2243801-2007-00007
    Event Type
    Other
    Date Received
    March 1, 2007
    Date of Event
    January 22, 2007
    Report Date
    February 16, 2007
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THIS INCIDENT WAS RETURNED TO THE MANUFACTURER TO BE EVALUATED. VISUAL INSPECTION INDICATES THE UNIT WAS NOT USED IN VIVO. THE RETURNED UNIT PASSES ALL CONTINUITY TESTING AND WAS NOTED TO FUNCTION PROPERLY. NO DEFECTS WERE NOTED IN THE RETURNED UNIT. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    PACING FAILURE. DURING USE, NO RESPONSE. DETERMINED BROKEN LEAD. TESTED A COUPLE OF TIMES WITH NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO. LTD PACING CATHETER DYB B. BRAUN MEDICAL, INC. NA 60827075

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other