BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1951384 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22846
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 20, 2010
    Report Date
    April 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR MONTHS LATER, THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES DISCUSSED THE REPORTED CLINICAL OBSERVATIONS WITH THE CALLER. THE DEVICE REMAINS ACTIVELY IMPLANTED AND 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 ON (B)(6) 2010, THIS PACEMAKER DISPLAYED A LONGEVITY REMAINING OF LESS THAN SIX MONTHS. ADDITIONALLY, THE BATTERY STATUS WAS JUST SLIGHTLY ABOVE ELECTIVE REPLACEMENT TIME (ERT) AND THE MAGNET RATE WAS 90PPM. MOST RECENTLY, THE GAS GAUGE WAS 1/3 FULL AND LONGEVITY REMAINING WAS ONE YEAR. THE CALLER REPORTED THE DAILY MEASUREMENTS ARE PRESENT AND THERE HAVE BEEN NO PROGRAMMING CHANGES MADE.

    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 93 YR (B)(4)| (B)(4)| 1290| 1274