BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 1771324 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12452
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    September 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A POCKET REVISION WAS PERFORMED, WITH NO ADVERSE PATIENT EFFECTS REPORTED. AVAILABLE INFORMATION SUGGESTS THAT THESE PRODUCT REMAIN IMPLANTED. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATES THAT THE PATIENT'S DEVICE, RV LEAD, AND LV LEAD WERE SUCCESSFULLY EXPLANTED DUE TO EROSION AND SYSTEM INFECTION. THESE PRODUCTS WERE SENT TO THE HOSPITAL'S PATHOLOGY DEPARTMENT, AND HAVE NOT BEEN RETURNED TO BOSTON SCIENTIFIC. THE PATIENT'S CHRONIC RA LEAD WAS UNABLE TO BE EXTRACTED, AND WAS SURGICALLY CAPPED AND ABANDONED. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT'S LEADS WAS EXPOSED DUE TO POCKET EROSION. THE PATIENT'S IMPLANTED LEADS INCLUDE TRANSVENOUS RIGHT VENTRICULAR (RV), LEFT VENTRICULAR (LV), AND RIGHT ATRIAL (RA) LEADS, AS WELL AS A PREVIOUSLY ABANDONED RV RATE/SENSE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention (B)(4)| H219| 4473| (B)(4)| 0181| MISMATCH| 1295| 4524| (B)(4)| 4517