BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2163461 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-08290
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY, ANALYSIS PERFORMED ON DISLODGED LEADS HAS NOT IDENTIFIED ANY DEVICE DEFECT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL EVENT. EXPERIENCE HAS SHOWN THAT THIS ISSUE IS LIKELY RELATED TO THE PATIENT'S CONDITION OR THE IMPLANT TECHNIQUE. THE RETURNED LEAD WILL NOT BE ANALYZED, BUT ARCHIVED SHOULD FUTURE TESTING BE REQUIRED. DISLODGEMENT TYPICALLY OCCURS CLOSELY FOLLOWING IMPLANT WHEN AN OPTIMAL TISSUE TO LEAD INTERFACE IS NOT ACHIEVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS EPICARDIAL LEAD DID BECOME DISLODGED POST POCKET CLOSURE, SHORTLY AFTER IMPLANT. THERE WERE NO ASSOCIATED ADVERSE PATIENT EFFECTS, BEYOND SURGICAL INTERVENTION TO ADDRESS THIS ISSUE.

    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 68 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)