BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1951005 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23329
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 15, 2010
    Report Date
    November 22, 2010
    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

    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 RECEIVED INFORMATION THAT SIX MONTHS PRIOR THIS PACEMAKER DISPLAYED LONGEVITY REMAINING OF 1.5 YEARS. CURRENTLY THE DEVICE PREDICTS THE ESTIMATED LONGEVITY REMAINING AT LESS THAN SIX MONTHS. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD THRESHOLD MEASUREMENTS HAD INCREASED. DURING A LEAD REVISION FOR HIGH THRESHOLD MEASUREMENTS, THIS DEVICE WAS EXPLANTED AND A NEW PACEMAKER WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 73 YR 5068| 1290| 1270