BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2780465 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12856
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    January 11, 2012
    Report Date
    September 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DEVICE CHANGE OUT PROCEDURE THIS CHRONIC LEFT VENTRICULAR (LV) LEAD EXHIBITED A LOSS OF CAPTURE AND IMPEDANCES GREATER THAN 2000 OHM WHEN USING ANY LV RING CONFIGURATION WITH THE NEW CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). NO IMPEDANCE WAS MEASURED THROUGH THE PACING SYSTEM ANALYZER USING THE RING CONFIGURATION. THE PHYSICIAN ELECTED TO KEEP THIS LV LEAD IMPLANT WITH THIS NEW CRT-D AND UTILIZED THE LV TIP IN A LV TIP TO COIL CONFIGURATION. IN THIS CONFIGURATION, THE LEAD HAD NORMAL SENSING, PACING IMPEDANCE, AND THRESHOLDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS LATER REPORTED THAT THE THRESHOLDS HAD INCREASED AND THE LEAD EXHIBITED GREATER THAN 2000 OHMS. AS A RESULT, THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. AGAIN, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 73 YR Hospitalization| L| R H217| MISMATCH| 4087| 4543| 6942| N119