BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1950300 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22411
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    February 8, 2010
    Report Date
    November 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED COMPLETE LOSS OF CAPTURE. THE PATIENT EXPERIENCED ACUTE EXACERBATION OF CONGESTIVE HEART FAILURE AND WAS HOSPITALIZED. THE PHYSICIAN MADE SOME ADJUSTMENTS PREVIOUSLY AND THE EFFECTIVENESS OF THOSE CHANGES HAD DIMINISHED. ADDITIONAL INFORMATION LATER RECEIVED INDICATED THAT THE LV LEAD WAS SURGICALLY CAPPED. NO FURTHER COMPLICATIONS HAVE BEEN 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 80 YR Hospitalization| R 4543| N119| 4542| 4185| (B)(4)| 4023| MISMATCH| 1280