BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR RMT

    MDR report key: 2173065 · Received July 8, 2011

    Report

    Report Number
    2173065
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC ABLATION, THE CATHETER DID NOT TRANSMIT A CONNECTION WHEN ATTACHED TO THE CABLE. A NEW CATHETER WAS OBTAINED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR RMT CATHETER, DIAGNOSTIC, CARDIAC, NAVIGATION DRF BIOSENSE WEBSTER, INC. * 15246-158MB

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR