BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2781016 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13218
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 25, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003/S106
    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 DISCUSSED THE REPORTED CLINICAL OBSERVATIONS AND SUSPECTS A DEVICE RESET TO BE THE CAUSE OF THE ODD BATTERY ESTIMATE. THE CONSULTANT RECOMMENDED ANOTHER DEVICE INTERROGATION TO VERIFY THE ESTIMATED TIME REMAINING. THE DEVICE REMAINS IMPLANTED AN NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SIX MONTHS AGO, THIS DEVICE DISPLAYED 1.5 YEARS OF REMAINING LONGEVITY. HOWEVER, CURRENTLY THE LONGEVITY REMAINING IS GREATER THAN FIVE YEARS. ALL OF THE DAILY MEASUREMENTS ARE STILL AVAILABLE AND INTERROGATION WAS UNREMARKABLE FOR ANY ISSUES. ADDITIONALLY, THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS AND NO CAPTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4469| 4470| S606