BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1953669 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23905
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    October 12, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR LEAD REVEALED IMPEDANCES GREATER THAN 2,000 OHMS SINCE (B)(6) 2010. LEFT VENTRICULAR PACING WAS NOT DELIVERED AT A THRESHOLD OF 7.5V. THE POLARITY WAS REPROGRAMMED FROM RING-COIL TO TIP-COIL. A CHEST X-RAY WAS PERFORMED AND REVEALED THAT THE LEAD WAS FRACTURED AT THE INSERTION SITE OF THE SUBCLAVIAN VEIN. THE PATIENT WAS ASYMPTOMATIC; THEREFORE, THE DECISION WAS MADE TO LEAVE THE LEAD IMPLANTED AND MONITOR THE PATIENT CLOSELY. NO ADVERSE PATIENT EFFECTS REPORTED.

    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 Other