BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1950960 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23316
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    September 30, 2010
    Report Date
    November 20, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THIS PACEMAKER EXHIBITED VARYING BATTERY LONGEVITY ESTIMATES. SEVEN MONTHS PRIOR 1.5 YEARS REMAINING WAS DISPLAYED, THREE MONTHS PRIOR LESS THAN 5 MONTHS REMAINING WAS DISPLAYED AND CURRENTLY ONE YEAR REMAINING WAS DISPLAYED. TECHNICAL SERVICES (TS) DISCUSSED AND NOTED THAT IT WAS LIKELY ONE YEAR REMAINING THAT WAS ACCURATE. 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 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)