BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER THERMOCOOL

    MDR report key: 6659571 · Received June 20, 2017

    Report

    Report Number
    MW5070547
    Event Type
    Malfunction
    Date Received
    June 20, 2017
    Date of Event
    June 19, 2017
    Report Date
    June 20, 2017
    Manufacturer
    BIOSENSE
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER (BIOSENSE WEBSTER THERMOCOOL SMART TOUCH D-F M# D132705, LOT #17654322M) WAS USED. THE CONNECTING CABLE WAS CHANGED DUE TO NOSE ON ELECTROGRAM, CAUSING FAILURE OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436719 BIOSENSE WEBSTER THERMOCOOL BIOSENSE WEBSTER THERMOCOOL LPB BIOSENSE 132705 17654322M

    Patients

    Seq Age Sex Outcome Treatment
    1