BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IROX

    MDR report key: 1860472 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-14963
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    June 10, 2010
    Report Date
    July 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

    THE LEAD REMAINS IN SERVICE AND 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 DURING THE ELECTIVE PROCEDURE TO REPLACE THIS PATIENT'S PACEMAKER, DAMAGE TO THIS ATRIAL OCCURRED. IT WAS NOTED THAT WHEN THE LEAD WAS PULLED OUT OF THE DEVICE HEADER, THE TERMINAL PIN WAS SEPARATED FROM THE ELECTRODE RING. THE REST OF THE LEAD BODY WAS INTACT AND ELECTRICALLY CONNECTED WITHIN THE LEAD.

    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 88 YR 294-03| 438-05| MISMATCH| 430-07