BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2173744 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11261
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW SYSTEM WAS IMPLANTED ON THIS PATIENT'S RIGHT SIDE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    (B)(4) RECEIVED INFORMATION THAT THIS SYSTEM WAS BEING EXPLANTED SECONDARY TO POCKET EROSION.

    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 79 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)