BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1771614 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13674
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    January 26, 2007
    Report Date
    June 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH DEVICE EVALUATION WAS PERFORMED. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT IN (B) (6) 2006, THIS PACEMAKER'S GAS GAUGE WAS AT 50% REMAINING. LEAD IMPEDANCE WAS 320 OHMS IN THE ATRIUM AND 600 OHMS IN THE VENTRICLE AND NO PROGRAMMING CHANGES WERE MADE. HOWEVER, ONE MONTH LATER, DEVICE LONGEVITY HAD CHANGED TO 75% REMAINING. LEAD IMPEDANCE HAD INCREASED TO 380 OHMS IN THE ATRIUM AND 640 OHMS IN THE VENTRICLE. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT STATED THAT DUE TO THE CHANGES IN IMPEDANCE MEASUREMENTS, THE DEVICE MIGHT HAVE BEEN USING DIFFERENT BINS TO ASSIGN THE GAS GAUGE STATUS. OVER TWO YEARS LATER, THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 1346T| 2360L| 1298| 1342T