BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1952232 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23749
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED. 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 A DECREASE IN REMAINING BATTERY LIFE WAS REPORTED. THE GAS GAUGE ON THE DEVICE NOTED 1.5 YEARS REMAINING AND UPON INCREASING THRESHOLD MEASUREMENTS THE DEVICE TRIGGERED ELECTIVE REPLACEMENT TIME (ERT) THREE DAYS LATER. THE PREVIOUS OUTPUTS WERE 3.5VOLTS AT 0.6MS IN THE RIGHT ATRIUM (RA) AND 2.4VOLTS AT 0.4MS IN THE RIGHT VENTRICLE (RV), 25% RA PACING AND 100% RV PACING. BEFORE THE DEVICE DECLARED ERT THE PATIENT HAD VALVE SURGERY AND A LEAD REVISION DUE TO REQUIRING AN EPICARDIAL LEAD (RECEIVED A MECHANICAL VALVE). AFTER THE LEAD REVISION, THE DEVICE OUTPUTS WERE INCREASED TO 4 VOLTS AT 0.4MS IN THE RA AND 5 VOLTS AT 0.4MS IN THE RV AND THE DEVICE DECLARED ERT SOON AFTER. PREMATURE BATTERY DEPLETION WAS SUSPECTED AND A DEVICE REVISION PROCEDURE WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR (B)(4)| (B)(4)| (B)(4)