BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAVISTAR DS EP CATHETER

    MDR report key: 651352 · Received November 11, 2005

    Report

    Report Number
    651352
    Event Type
    Other
    Date Received
    November 11, 2005
    Date of Event
    September 7, 2005
    Report Date
    November 11, 2005
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE CATHETER WAS IN THE LEFT ATRIUM OF THE PATIENT'S HEART, AN ERROR MESSAGE WAS SHOWN THAT THE CATHETER HAD A TEMPERATURE LIMITER ISSUE. TROUBLE SHOOTING WAS PERFORMED AND THIS COULD NOT BE CORRECTED. NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR DS EP CATHETER ABLATION CATHETER LPB BIOSENSE WEBSTER 13042516 *
    2 NAVISTARDS EP CATHETER ABLATION CATHETER LPB BIOSENSE WEBSTER 13042516 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *