BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2161212 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07388
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS 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 IN A LETTER FROM ANOTHER MANUFACTURE, THAT THIS LEFT VENTRICULAR LEAD DISPLAYED IMPEDANCE MEASUREMENT GREATER THAN 2000 OHMS AND NO SENSING. IT WAS REPORTED THAT THE LEAD WILL BE EXTRACTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE LEAD WAS CAPTURING.

    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 77 YR MISMATCH| (B)(4)