BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER - ABLATION

    MDR report key: 1061639 · Received June 8, 2008

    Report

    Report Number
    1061639
    Event Type
    Malfunction
    Date Received
    June 8, 2008
    Date of Event
    April 22, 2008
    Report Date
    June 8, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ECG SIGNAL DISPLAYED INAPPROPRIATE NOISE. ALL CONNECTIONS CHECKED AND CATHETER HANDLE REPLACED WITH ANOTHER HANDLE. THIS DID NOT RESOLVE THE ISSUE. FINALLY THE CATHETER WAS THEN EXCHANGED FOR ANOTHER BRAND-NEW CATHETER AND THIS RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER - ABLATION CATHETER, ABLATION OAD BIOSENSE WEBSTER, INC. NA 13276491

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR