BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1944710 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20049
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003/S106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO INTERVENTION HAS BEEN PERFORMED. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT DEVELOPED AN INFECTION AND THE ENTIRE PACING SYSTEM IS SCHEDULED TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S404

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 4136| S404| 4137