BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1852157 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-16131
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 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

    THE BOSTON SCIENTIFIC CRM SALES REPRESENTATIVE WAS NOT AWARE OF ANY DEVICE ANOMALIES. SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER EXPERIENCED AN UNSPECIFIED MALFUNCTION. OUR COMPANY HAS NO SPECIFIC INFORMATION REGARDING THIS ALLEGATION.

    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 84 YR 5076| S606| 5592