BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3040778 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02582
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LV LEAD IS EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A PROCEDURE FOR A NON BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD, THIS LEFT VENTRICULAR (LV) LEAD DISPLAYED HIGH OUT OF RANGE PACE IMPEDANCES AND LOSS OF CAPTURE. AS A RESULT THIS LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143372 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 4076| N140| H210| 4542| MISMATCH| 6949| 0293| N119