BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2243801-1999-00040

    MDR report key: 256891 · Received December 22, 1999

    Report

    Report Number
    2243801-1999-00040
    Event Type
    Malfunction
    Date Received
    December 22, 1999
    Date of Event
    November 1, 1999
    Report Date
    November 29, 1999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RETURN REASON; THE CUSTOMER REPORTED THE CATHETER HAD A PROBLEM OF IMPOSSIBLE PACING. ANALYSIS DETERMINED; INVESTIGATION FOUND THAT THE PROXIMAL ELECTRODE WIRE IS BROKEN AT THE PROXIMAL EDGE OF THE ELECTRODE, ALLOWING AN OPEN CIRCUIT TO OCCUR. CAUSE IS UNKNOWN. NO MANUFACTURING DEFECTS WERE FOUND. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. CORRECTIVE ACTION TAKEN; THE CORRECTIVE ACTION IS THAT MANUFACTURING AND QUALITY ASSURANCE PERSONNEL HAVE BEEN NOTIFIED. BOTH THE FREQUENCY AND SEVERITY OF THIS TYPE OF INCIDENT WILL BE CLOSELY MONITORED TO DETERMINE IF FURTHER CORRECTIVE ACTION IS NECESSARY.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other