BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IROX

    MDR report key: 3242521 · Received July 23, 2013

    Report

    Report Number
    2124215-2013-11710
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 PROCEDURE FOR NORMAL BATTERY DEPLETION, IT WAS OBSERVED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD INSULATION ISSUES AT THE TERMINAL PIN AREA. THEREFORE, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THERE WERE NOT ANY PERFORMANCE ISSUES FROM THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343141 IROX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 431-07

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 407-04| 294-03| 1184| K172| MISMATCH| 431-07| 1190