BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IROX

    MDR report key: 2914376 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00735
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    August 31, 2012
    Report Date
    December 17, 2012
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEADS WERE INSERTED INTO THE CORRECT PORTS AND REMAIN IN SERVICE WITHOUT FURTHER COMPLICATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. AN AMENDED REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOUR DAYS AFTER A DEVICE REPLACEMENT PROCEDURE, A LEAD REVISION WAS REQUIRED BECAUSE THIS CHRONIC RIGHT VENTRICULAR (RV) LEAD AND THE CHRONIC RIGHT ATRIAL (RA) LEAD WERE REVERSED IN THE DEVICE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19726 IROX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 431-07

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R 284-09| ADDRL1| 431-07| 435-07| 0982