BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2050269 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04670
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY CANNOT CONFIRM THE OBSERVED CLINICAL OBSERVATION OF DISLODGEMENT. HOWEVER, EVIDENCE AND PAST EXPERIENCE SUGGESTS THAT LEAD DISLODGEMENT CAN BE THE RESULT OF UNIQUE PATIENT PHYSIOLOGY AND /OR IMPLANT TECHNIQUE (WHICH IS OFTEN DICTATED BY PATIENT ANATOMY). LEAD DISLODGEMENT IS A POTENTIAL COMPLICATION OF IMPLANTABLE PACING AND IS DESCRIBED IN DEVICE LABELING. THIS EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WAS REMOVED FROM SERVICE ONE DAY POST IMPLANT DUE TO DISLODGEMENT. 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