BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IROX

    MDR report key: 3043118 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03015
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A GENERATOR CHANGE-OUT THIS RIGHT VENTRICULAR (RV) LEAD WAS TESTED AND HAD NORMAL MEASUREMENTS. THE LEAD WAS INSERTED INTO THE NEW DEVICE AND THE SET SCREWS WERE TIGHTENED. THE PHYSICIAN THEN OBSERVED THAT THIS LEAD'S TERMINAL PIN HAD BECOME LOOSE AND, ON FURTHER INSPECTION, HAD COME SEPARATED FROM THE LEAD. THIS LEAD WAS THE SURGICALLY ABANDONED. A NEW LEAD WAS NOT ABLE TO BE PLACED DUE TO VEIN OCCLUSION. THE NEXT DAY A NEW SYSTEM WAS IMPLANTED ON THE PATIENT'S OTHER SIDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145641 IROX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 430-07

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR K173| (B)(4)| (B)(4)| (B)(4)