BEUDAMED
    FDA Adverse Event Other Summary report: N

    GOODMAN CO. LTD

    MDR report key: 859601 · Received June 1, 2007

    Report

    Report Number
    2243801-2007-00014
    Event Type
    Other
    Date Received
    June 1, 2007
    Date of Event
    April 24, 2007
    Report Date
    May 23, 2007
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MFR TO BE EVALUATED. THE RETURNED UNIT DID NOT PASS PROXIMAL CONTINUITY TESTING. THE RETURNED UNIT WAS SLICED AT THE MANIFOLD AND IT WAS DETERMINED THAT THERE IS A BREAK IN THE PROXIMAL WIRE INSIDE THE MANIFOLD. VISUAL INSPECTION OF THE UNIT INDICATES THAT THE WIRE IS BROKEN AT THE END OF THE SOLDER AREA. THIS INCIDENT MAY BE ATTRIBUTED TO HANDLING DURING MANUFACTURING AFTER SOLDERING, OR NOT BEING PROPERLY HANDLED BY THE PHYSICIAN DURING THE PROCEDURE.

    Description of Event or Problem · 1

    PACING FAILURE; A BREAKAGE OF LEAD DURING USE IS CONSIDERED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO. LTD PACING CATHETER DYG B. BRAUN MEDICAL, INC. NA 60893766

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other