BEUDAMED
    FDA Adverse Event Summary report: N

    NAVISTAR THERMOCOOL IRRIGATED TIP

    MDR report key: 1053111 · Received May 21, 2008

    Report

    Report Number
    1053111
    Date Received
    May 21, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    OAD
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ELECTROCARDIOGRAM SIGNAL ON THE NAVISTAR THERMOCOOL IRRIGATED TIP ABLATION CATHETER DISPLAYED INAPPROPRIATE NOISE. ALL CONNECTIONS WERE CHECKED AND THE CATHETER HANDLE WAS REPLACED WITH ANOTHER HANDLE. THIS DID NOT RESOLVE THE ISSUE, AND FINALLY THE CATHETER WAS THEN EXCHANGED FOR A NEW CATHETER, WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR THERMOCOOL IRRIGATED TIP CATHETER, ABLATION, RF OAD BIOSENSE WEBSTER NI75TCFH 13276491

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR