BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2170308 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10037
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 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

    THE FIELD REPRESENTATIVE REPORTED THAT THIS PATIENT WAS NOT FOLLOWED BY LISTED PHYSICIAN AND HAD NO FURTHER INFORMATION TO PROVIDE. ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN IN SERVICE. 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) WAS PART OF AN ADVISORY AND WAS MALFUNCTIONING. THERE WAS INQUIRY AS TO WHAT ADVISORY AND TECHNICAL SERVICES DISCUSSED. IN ADDITION, THERE WAS AN ALERT TO CHECK THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL AND LEFT VENTRICULAR LEADS. THE HEALTH CARE PROVIDER WAS TO FURTHER DISCUSS THIS CASE WITH THE PHYSICIAN. 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 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 4542| N119| MISMATCH| 350 974| 350 973| 0157