BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2071468 · Received April 28, 2011

    Report

    Report Number
    2124215-2011-07475
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CRT-D AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RATE/SENSE CHANNEL. THE NOISE WAS OVERSENSED WHICH RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND APPROXIMATELY FIVE SECONDS OF PACING INHIBITION. THE PATIENT WAS LATER BROUGHT INTO CLINIC FOR FURTHER EVALUATION. IT WAS REPORTED THAT THE PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTED. IT WAS NOTED THAT THE PATIENT HAD NUMEROUS VENTRICULAR FIBRILLATION (VF) EPISODES IN WHICH UNDERSENSING OCCURRED AND THE PATIENT REQUIRED EXTERNAL DEFIBRILLATION. UPON DEVICE INTERROGATION FOLLOWING THE EXTERNAL SHOCKS, A MESSAGE WAS DISPLAYED INDICATING HIGH VOLTAGE DETECTION ON SHOCKING COILS. TECHNICAL SERVICES DISCUSSED THIS MESSAGE WAS DISPLAYED DUE TO AN EXTERNAL SHOCK BEING DELIVERED WHILE THE DEVICE WAS CHARGING FOR THERAPY DELIVERY. APPROXIMATELY TEN DAYS LATER, THE DEVICE WAS FOUND TO HAVE REACHED END OF LIFE. AS THE PATIENT HAS AN LVAD, THE PHYSICIAN WAS NOT CONCERNED ABOUT CARDIAC OUTPUT OR TACHYCARDIA EPISODES. TACHY THERAPY WAS ELECTIVELY PROGRAMMED OFF AND BRADY THERAPY REMAINS AVAILABLE FOR PACING SUPPORT. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. AS OF TODAY, AVAILABLE INFORMATION INDICATES THE SYSTEM REMAINS 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 66 YR Life Threatening| R H170| 0158| 4543