BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2042473 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01327
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THE RV LEAD HAD FRACTURED. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A NON-BSC LEAD. THIS CRT-D AND THE LV LEAD REMAINED ACTIVELY IN SERVICE WITHOUT FURTHER ISSUE. TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. UNTIL THEN, THE INVESTIGATION REMAINS OPEN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR IN ASSOCIATION WITH THE TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD AND THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD DID EXHIBIT GREATER THAN 2,000 OHMS PACE IMPEDANCE MEASUREMENTS RESPECTIVELY. THERE WAS SOME NOISE PRESENT ON THE EPISODES THAT WERE VIEWED. AS A RESULT OF NOISE OVERSENSING, THE PATIENT DID RECEIVE SOME INAPPROPRIATE SHOCKS. THE PATIENT HAD A FALL ABOUT ONE MONTH PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR (B)(4)| 4542| H170| N119| 0185| MISMATCH