BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IROX

    MDR report key: 1951420 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22979
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    September 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION RECEIVED INFORMATION THAT THIS LEAD AND NON-BOSTON SCIENTIFIC DEVICE WERE REMOVED DUE TO INFECTION. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IROX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 430-07

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 430-07| 292-03