BEUDAMED
    FDA Adverse Event Other Summary report: N

    GOODMAN CO. LTD

    MDR report key: 838170 · Received April 13, 2007

    Report

    Report Number
    2243801-2007-00012
    Event Type
    Other
    Date Received
    April 13, 2007
    Date of Event
    March 6, 2007
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYG
    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 MANUFACTURER TO BE EVALUATED. THE RETURNED UNIT DID NOT PASS PROXIMAL CONTINUITY TESTING. EVALUATION FOUND EVIDENCE OF SOLDER AT THE CONNECTION, HOWEVER, THE WIRE IS DISCONNECTED FROM PROXIMAL ELECTRODE. THE PROXIMAL WIRE MAY HAVE DISCONNECTED FROM THE ELECTRODE DURING HANDLING. THIS INCIDENT MAY ALSO BE ATTRIBUTED TO THE UNITE BEING PASSED THROUGH A TIGHT INTRODUCER. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    PACING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO. LTD PACING CATHETER DYG B. BRAUN MEDICAL, INC. NA 60884890

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other