BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK

    MDR report key: 2173877 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-12289
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    November 22, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED OR UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC. 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD HAD A TRICUSPID VALVE RECONSTRUCTION AND MITRAL VALVE REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THIS LEAD EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT. EXIT BLOCK WITH NO STIMULATION AFTER PACING WAS ALSO NOTED THIS LEAD WAS EXPLANTED AND A NEW LV LEAD WILL BE IMPLANTED IN THE FUTURE. THIS LEAD WILL BE RETURNED TO BOSTON SCIENTIFIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD OJX GUIDANT PUERTO RICO BV 4512

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)