BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1771589 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13103
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2009
    Report Date
    June 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACEMAKER REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW-UP VISIT, THIS PACEMAKER HAD DISPLAYED 1.5 YEARS REMAINING. TWO MONTHS PRIOR THE LONGEVITY REMAINING WAS <.5 YEARS REMAINING. THE LONGEVITY REMAINING HAD FLUCTUATED DRAMATICALLY THE YEAR BEFORE AS WELL. A MEMORY SAVE TO DISK WAS PERFORMED AND ANALYZED BY A PRODUCT ENGINEER. THE AUTOMATIC CAPTURE FEATURE WAS PROGRAMMED ON AND IT WAS SUSPECTED THAT THE <.5 YEARS REMAINING READING OCCURRED WHEN THE DEVICE WAS IN A RETRY MODE WHICH INCREASED THE OUTPUT TEMPORARILY. THE 1.5 YEARS REMAINING WAS THE APPROPRIATE READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4480| 1290| 4459