BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT

    MDR report key: 1062170 · Received June 10, 2008

    Report

    Report Number
    1062170
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S CHEST X-RAY SHOWED THAT THE RIGHT VENTRICULAR LEAD THAT WAS PLACED WAS NOT IN THE APPROPRIATE POSITION. THE CHEST X-RAY THE FOLLOWING DAY SHOWED PROPER POSITION. DFT (DEFIBRILLATION THRESHOLD) TESTING WAS NOT DONE FOLLOWING THE ORIGINAL IMPLANTATION PROCEDURE SECONDARY TO HEMODYNAMIC AND AIRWAY INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT LEAD, ICD LWS BOSTON SCIENTIFIC 0158 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR NO OTHER THERAPIES| NO OTHER THERAPIES