BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1571343 · Received December 8, 2009

    Report

    Report Number
    2124215-2009-28001
    Event Type
    Malfunction
    Date Received
    December 8, 2009
    Date of Event
    November 10, 2009
    Report Date
    December 8, 2009
    Manufacturer
    GUIDANT CORPORATION
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVENT WILL BE UPDATED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT A JOURNAL ARTICLE PUBLISHED BY DR. BEAT SCHAER POINTED TO A STUDY OF 644 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) - 189 OF WHICH WERE MANUFACTURED BY GUIDANT - ALLEGING THAT THE DEVICES DID NOT MEET LONGEVITY EXPECTATIONS REGARDLESS OF PROGRAMMED PARAMETERS FOR PACING AND SHOCK DELIVERY. THE DEVICES WERE IMPLANTED FROM 1994 TO 1999. THE MEDIAN LONGEVITY FOR GUIDANT DEVICES WAS 5.0 YEARS. AFTER 5 YEARS, 70% OF ALL THE STUDY'S ICDS WERE STILL IN SERVICE COMPARED TO THE 80% PROJECTED BY INDUSTRY. ALSO, 13% OF THE PTS WITH GUIDANT DEVICES DIED PRIOR TO DEVICE EARLY ERI BUT THERE WAS NO INFO THAT DIRECTLY CORRELATED THE DEATHS TO THE DEVICES THAT TRIGGERED EARLY ERI. SPECIFIC MODELS ARE UNK AND WE HAVE BEEN UNABLE TO OBTAIN MORE INFO. (SCHAER, B.A., KOLLER, M.T., STICHERLING, C., ALTMANN, D., JOERG, L., OSSWALD, S., LONGEVITY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD), INFLUENCING FACTORS AND COMPARISON TO INDUSTRY-PROJECTED LONGEVITY. HEART RHYTHM (2009), DOI: 10.1016/J.HRTHM.2009.09.013.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE NIK GUIDANT CORPORATION TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1