BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2173651 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11112
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS ON THE LEFT VENTRICULAR (LV) LEAD. THERE WAS NO NOISE PRESENT ON THE LV CHANNEL AND THE OUTPUT WAS SET AT 2.5 VOLTS AT .8 MILLISECONDS. THE THRESHOLD MEASUREMENTS WERE REPROGRAMMED TO 4 VOLTS AT 1 MILLISECOND WITH NO MUSCLE STIMULATION NOTED. IT WAS NOTED THE CONFIGURATION WAS LV TIP TO LV RING. TECHNICAL SERVICES (TS) RECOMMENDED TRYING DIFFERENT CONFIGURATIONS TO SEE IF MEASUREMENTS ARE THE SAME OR IMPROVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    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 82 YR 5034| H177| N119| MISMATCH| 4469| KDR401| H170| 0184| 4542