BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1852160 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-15097
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE EXPLANTED LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE LEAD IS RETURNED IT WILL BE ARCHIVED AS ANALYSIS TESTING CANNOT REPLICATE DISLODGEMENT FOR THIS PASSIVE TINED LEAD. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WAS EXPLANTED DUE TO DISLODGEMENT. THE LEAD WAS REPLACED WITH ANOTHER MANUFACTURES. 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 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R 4543| MISMATCH