BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE 0127/101433 IMPLANTED 13-JUN-2001

    MDR report key: 1683552 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-06864
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    July 16, 2009
    Report Date
    April 11, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, RIGHT VENTRICULAR PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE 0127/101433 IMPLANTED 13-JUN-2001 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR