BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3232708 · Received July 18, 2013

    Report

    Report Number
    2124215-2013-11463
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE. IN ADDITION, THE LEAD PACING IMPEDANCE MEASUREMENT WAS MORE THAN 2000 OHMS. TESTS WERE DONE AND IT APPEARED THAT THE LEAD HAD A CONDUCTOR FRACTURE. THEN, THE PHYSICIAN TRIED TO IMPLANT A DIFFERENT LEAD BUT WAS UNSUCCESSFUL. THE PHYSICIAN REPLACED THE DEVICE ELECTIVELY AND CAPPED THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND THE LEAD WERE OUT OF SERVICE. ADDITIONAL INFORMATION RECEIVED. THE ATTEMPTED IMPLANT WAS A COMPETITOR LEAD. NO NOISE WAS DETECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333278 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R