BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2041762 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00949
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REVISED AND PLACED SUB PECTORAL DUE TO A REPORTED EROSION. IT WAS LATER REPORTED THAT THE SUTURE SLEEVE HAD POPPED THROUGH THE SUTURES. THERE WAS VERY THIN SKIN OVER THE DEVICE. THE LEADS REMAIN UNCHANGED AT THIS TIME. NO OTHER PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)