BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2011-00478

    MDR report key: 2040115 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00478
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. 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 THAT THIS IMPLANTABLE CARDIOVERTER DISPLAYED A RED ERROR SCREEN STATING VOLTAGE IS TOO LOW FOR PROJECTED LONGEVITY. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVN GUIDANT PUERTO RICO BV

    Patients

    Seq Age Sex Outcome Treatment
    1