BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 1212659 · Received October 24, 2008

    Report

    Report Number
    2124215-2008-99964
    Event Type
    Death
    Date Received
    October 24, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 24, 2008
    Manufacturer
    GUIDANT PACEMAKERS, INC., GUIDANT PUERTO RICO B.V.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. NO PRODUCTS HAVE BEEN RETURNED FOR TESTING. THEREFORE, BSC CRM CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT LOW R-WAVES AND HIGH THRESHOLDS WERE NOTED WITH THIS VENTRICULAR LEAD. LEAD REPOSITIONING WAS UNSUCCESSFUL. A REPLACEMENT DEXTRUS LEAD WAS IMPLANTED. HOWEVER, INADEQUATE SENSING WAS NOTED AND THE LEAD WOULD NOT STAY IN PLACE. NEXT, A FLEXTEND LEAD WAS IMPLANTED. THE PATIENT'S CONDITION BEGAN TO DETERIORATE AND A PERFORATION AND PERICARDIAL EFFUSION WERE SUSPECTED. THE PATIENT WAS ASYSTOLIC AND A THORACTOMY AND HEART MASSAGE WERE PERFORMED WHILE CARDIOPULMONARY RESUSCITATION (CPR) WAS PROVIDED. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM BUT A PERFORATION WAS NOT CONFIRMED. APPROXIMATELY ONE WEEK LATER, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD DTB GUIDANT PACEMAKERS, INC., GUIDANT PUERTO RICO B.V. 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 Death