BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1210904 · Received October 22, 2008

    Report

    Report Number
    MW5008737
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 5, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ISSUE WAS FAILURE TO PACE -BY THE ICD- IN A PACER DEPENDENT PT, DUE TO ANOMALOUS BEHAVIOR OF A NEW ALGORITHM IN THE DEVICE. THE DEVICE IS BOSTON SCIENTIFIC 100-D COGNIS. THE COMPANY REP WAS HEARD TO SAY "OH, TRY IT AGAIN, THIS HAS OCCURRED BEFORE." THE SURGEON REFUSED TO TRY IT AGAIN BECAUSE THE PT WAS IN ASYSTOLE. A NEW -DIFFERENT- DEVICE WAS USED AND WAS SUCCESSFUL. THE PT IS DOING WELL. THE COMPANY REP TOOK THE MALFUNCTIONING DEVICE WITH HIM. DIAGNOSIS OR REASON FOR USE: ADJUSTMENT AICD; CHF. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC ICD PACER LWS BOSTON SCIENTIFIC 100-D COGNIS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening