BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA ULTRA

    MDR report key: 1043142 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33503
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 14, 2008
    Report Date
    May 31, 2011
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NVZ
    Removal / Correction Number
    Z1293/99-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER'S ESTIMATED REMAINING LONGEVITY WENT FROM GREATER THAN 5 YEARS REMAINING TO 3.5 YEARS REMAINING OVER SIX MONTHS TIME WITH NO CHANGES TO THE PROGRAMMED PARAMETERS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. INFORMATION WAS SUBSEQUENTLY RECEIVED THAT THIS DEVICE WAS ELECTIVELY REPLACED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA ULTRA IMPLANTABLE PULSE GENERATOR NVZ CARDIAC PACEMAKERS, INC 1290 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other THE DEVICE 4524/LAR145 WAS IMPLANTED 07-AUG-1998| THE DEVICE 4024/LAJ321 WAS IMPLANTED 07-AUG-1998| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 1998| THE DEVICE(B)(4) WAS IMPLANTED (B)(6) 1998