BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2163140 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07763
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE LEAD WAS DISLODGED AND A NON-BOSTON SCIENTIFIC LEAD WAS SUCCESSFULLY IMPLANTED. INVESTIGATION IS COMPLETED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A DAY AFTER IMPLANT THIS LEFT VENTRICULAR LEAD APPEARED TO BE OVERSENSING THE RIGHT VENTRICLE. A THRESHOLD TEST WAS UNSUCCESSFUL. THERE APPEARED TO BE NO CAPTURE OF THE LEFT VENTRICLE. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING. 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 Required Intervention