BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2192647 · Received August 5, 2011

    Report

    Report Number
    2124215-2011-13370
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 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

    TROUBLESHOOTING WAS TO BE DONE. MOST RECENTLY, THE ICD WAS EXPLANTED FOR UNKNOWN REASON. DURATION OF ASYSTOLE, IF ANY MAY HAVE OCCURRED, REMAINS UNKNOWN AS THOUSANDS OF EPISODES HAD OCCURRED. UPON RECEIPT AT OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE ICD WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LEADS WERE INSERTED INTO ALL PORTS WITHOUT DIFFICULTY. ANALYSIS (BOTH DISK WHILE IMPLANTED AND POST-EXPLANT ANALYSIS) FURTHER NOTED THAT THE PATIENT'S NEED AND USE OF THE LVAD WAS CREATING THE VT UNDERSENSING. THIS RV LEAD REMAINS ACTIVELY IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THIS RIGHT VENTRICULAR (RV) LEAD FAILED TO DETECT SLOW VENTRICULAR TACHYCARDIA (VT) AS A RESULT OF UNDERSENSING. BASELINE NOISE WAS ALSO NOTED, CAUSING OVERSENSING SUSPECTED TO BE THE RESULT OF THE PRESENCE OF AN EXTERNAL LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE BOSTON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE CONFIRMED THAT TO THE BEST OF HIS KNOWLEDGE, THE PATIENT HAD NOT BEEN WITHOUT CRITICAL THERAPY AND THERE WERE NO ADVERSE PATIENT SYMPTOMS. THE DEVICE WAS PROGRAMMED WITH A WIDE MONITOR ONLY TACHY ZONE OF 130 TO 190 BEATS PER MINUTE. THE PATIENT WAS ALSO NOTED TO HAVE BEEN STABLE SINCE RECEIVING THE LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 301 MO Required Intervention (B)(4)| (B)(4)