BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043251 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02034
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A SYNCOPAL EPISODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED REGARDING THIS ISSUE AND INDICATED THAT THE DEVICE IS SET UP WITH A MONITOR ONLY ZONE, VT-1 ZONE PROGRAMMED AT 150, VT ZONE PROGRAMMED AT 180, AND VT ZONE PROGRAMMED AT 200. THE RHYTHM IN QUESTION STARTED AS VT IN THE VT ZONE AND THEN ACCELERATED INTO THE VF ZONE. THERE WERE TWO BEATS OF UNDERSENSING PRIOR TO THE V-DETECT AND SOME DURING CHARGE. THE RHYTHM DETERIORATED TO VF JUST PRIOR TO CHARGE. TS DISCUSSED RATE CUT OFF FOR THE VARIOUS ZONES AND DURATION AND INDICATED IT WAS UNLIKELY ANY PROGRAMMING COULD PREVENT THE PATIENT FROM PASSING OUT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145304 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R 0158| 4053| T127| E110