BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IROX

    MDR report key: 4132315 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14809
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ROUTINE DEVICE REPLACEMENT, THIS RIGHT VENTRICULAR (RV) LEAD APPEARED TO BE CAUGHT OR STUCK IN THE DEVICE HEADER REQUIRING EXCESSIVE FORCE TO PULL THE LEAD OUT OF THE HEADER. THE LEAD WAS SUCCESSFULLY REMOVED FROM THE DEVICE HEADER, HOWEVER, THE TERMINAL PIN SEPARATED FROM THE RING. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612660 IROX IMPLANTABLE LEAD DTB GUIDANT ANGLETON/ST. PAUL 430-07

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 430-07| K173| 4470| 4054| 1297| MISMATCH