BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2161608 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-06922
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    July 9, 2010
    Report Date
    April 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A LEAD FRACTURE WAS CONFIIRMED AT 397 MM, DUE TO THE SUTURE SLEEVE TIE DOWN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS IN ALL CONFIGURATIONS EXPECT LV TIP TO COIL WHERE PACING IMPEDANCE MEASUREMENTS WER 448 OHMS. THE THRESHOLDS MEASUREMENTS ARE NORMAL AND STABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, THE PATIENT UNDERWENT A HEART TRANSPLANT AND THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 4543| 4473| H217| 0185