BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IROX

    MDR report key: 1864147 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15992
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    November 19, 2003
    Report Date
    August 9, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K890412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 CRM RECEIVED INFORMATION THAT THIS PACING SYSTEM HAD BEEN EXPLANTED SEVEN YEARS AGO DUE TO AN INFECTION. A NON-BSC REPLACEMENT SYSTEM WAS IMPLANTED.

    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 87 YR (B)(4)| (B)(4)| (B)(4)| 0064| MISMATCH| 7230E