BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1952754 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23807
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 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

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT INFORMED THE CALLER THAT THE HIGHER OUTPUTS COULD HAVE AN IMPACT ON DEVICE LONGEVITY. THE CONSULTANT ALSO EXPLAINED HOW THE GAS GAUGE FUNCTIONS. FURTHER TROUBLESHOOTING WAS DISCUSSED WHICH WILL BE REVIEWED WITH THE PHYSICIAN. 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 RECEIVED INFORMATION EVALUATION OF THIS PACEMAKER NOTED THE GAS GAUGE WAS AT BEGINNING OF LIFE (BOL), HOWEVER, LONGEVITY REMAINING WAS AT TWO YEARS. ATRIAL OUTPUT WAS PROGRAMMED TO 4.5 V AT 0.5 MS DUE TO HIGH THRESHOLDS.

    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 78 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)