BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1874839 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17964
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT SUGGESTED PERFORMING A DOWNLOAD OF THE DEVICE MEMORY WHICH CANNOT BE PERFORMED AT THIS TIME. THE CONSULTANT STATED THAT IF THE DEVICE WAS IN RETRY, THE BEHAVIOR EXHIBITED MAY OCCUR BECAUSE THE DEVICE WOULD OPERATE IN THE NEXT HIGHER CURRENT BIN AND ITS LONGEVITY WOULD BE AFFECTED. CURRENTLY THE DEVICE LOOKS LIKE IT SHOULD HAVE 3.5 YEARS LONGEVITY REMAINING. THE CONSULTANT SUGGESTED ANOTHER INTERROGATION OF THE DEVICE AND A COMPLETE MEMORY DUMP BE PERFORMED WHEN POSSIBLE. 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 SIX MONTHS AGO, THIS PACEMAKER DISPLAYED A LONGEVITY OF 4.5 YEARS REMAINING AND TODAY IT IS DISPLAYING 1.5 YEARS OF LONGEVITY REMAINING. IT WAS NOTED THAT THE DEVICE HAS BEEN IN RETRY THREE TIMES IN THE PAST MONTH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 4469| 4087| 425-06-58| 1273| 1291