BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1870920 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-16983
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RA LEAD WAS CONNECTED TO THE NEW DEVICE AND THE ISSUE RESOLVED. THE RV LEAD REMAIND IMPLANTED WITH THE NEW DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A DEVICE CHANGE-OUT PROCEDURE THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED LOSS OF CAPTURE FOR 2-3 BEATS. THIS OCCURRED WHEN THE RIGHT ATRIAL (RA) LEAD WAS MANIPULATED AND STILL CONNECTED TO THE OLD DEVICE. THE RV LEAD WAS CONNECTED TO THE NEW DEVICE AND WAS NOT TIED TO ANY CONFIGURATIONS WITH THE RA LEAD. THE PATIENT WAS PACEMAKER DEPENDENT. HOWEVER, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 4513| 4470| 0158| H179| H219