BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951569 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23607
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 27, 2010
    Report Date
    November 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE, RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE PATIENT WAS BROUGHT INTO THE OFFICE FOR TROUBLESHOOTING AND IMPEDANCE WAS WITHIN RANGE, WITH AND WITHOUT ISOMETRICS. DATA IN LATITUDE REVEALED THAT BOTH RV AND LV IMPEDANCE HAVE BEEN GREATER THAN 2,000 OHMS ON EVERY DAILY MEASUREMENT FOR APPROXIMATELY THE PAST 2 WEEKS. THERE WERE EPISODES DISPLAYING NOISE ON THE RV CHANNEL. THE POCKET WAS OPENED FOR FURTHER EVALUATION. THE PHYSICIAN TUGGED ON THE RV LEAD AND THE CONNECTION WAS SECURE, HOWEVER, IT APPEARED THAT THE LEAD MAY NOT HAVE BEEN ADVANCED FULLY INTO THE HEADER. THE PHYSICIAN DISCONNECTED THE RV LEAD FROM THE DEVICE AND TESTED THE LEAD WITH THE PACING SYSTEM ANALYZER. THE LEAD WAS RECONNECTED TO THE DEVICE AND THE PHYSICIAN CONFIRMED THAT A SECURE CONNECTION HAD BEEN ESTABLISHED. ALL DIAGNOSTICS WERE WITHIN RANGE FOLLOWING RECONNECTION. MULTIPLE IMPEDANCE TESTS WERE PERFORMED WITH POCKET MANIPULATION AND ALL REVEALED NORMAL IMPEDANCE MEASUREMENTS. NO FURTHER IMPEDANCE ISSUES HAVE BEEN REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE AND LEADS REMAIN IN SERVICE.

    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 76 YR Required Intervention N119| 1488T| H170| 0158| 4542