BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IROX

    MDR report key: 1945664 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20842
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    September 16, 2010
    Report Date
    October 12, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT FOLLOWING AN ELECTIVE PROCEDURE TO REPLACE THIS PATIENT'S PACEMAKER, THIS RIGHT VENTRICULAR LEAD WAS EXHIBITING DECREASED IMPEDANCE MEASUREMENTS AND VARYING R-WAVES MEASUREMENTS BETWEEN THE PACING SYSTEM ANALYZER (PSA) AND THE PACEMAKER. THEREFORE, THE POCKET WAS RE-OPENED TO EVALUATE THE LEAD AND AND INSULATION DAMAGE WAS OBSERVED. THE LEAD WAS REMOVED FROM SERVICE AND SUCCESSFULLY REPLACED. A FEW WEEKS FOLLOWING THIS PROCEDURE, THE PATIENT STATED THAT A PNEUMOTHORAX HAD OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IROX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 431-07

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 294-03| 4457| 431-07| 1284| S603| 438-05| 5076