BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1951968 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23114
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    October 11, 2010
    Report Date
    November 30, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 TO Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER. THE CALLER WILL CHECK THE INDICATORS AT THIS PATIENT'S NEXT FOLLOW UP VISIT. 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 THIS PACEMAKER DISPLAYED A MAGNET RATE OF 90PPM AND GREATER THAN TWO YEARS OF BATTERY LONGEVITY REMAINING. THE CALLER WAS INQUIRING ABOUT THE CONFLICTING INDICATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 4470| 4471| 1297