BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL

    MDR report key: 1894369 · Received November 9, 2010

    Report

    Report Number
    2124215-2010-21821
    Event Type
    Death
    Date Received
    November 9, 2010
    Date of Event
    October 16, 2010
    Report Date
    December 4, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1192-06 THRU Z-1194-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CRT-D WAS DEACTIVATED, AND WILL BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED BODY FLUID CONTAMINATION IN THE LEFT VENTRICULAR (LV) BARREL. ALL THE SEAL PLUGS WERE INTACT, AND ALL SETSCREWS OPERATED NORMALLY. THE BATTERY STATUS WAS IN MIDDLE OF LIFE 2 (MOL 2) WITH A MONITORING VOLTAGE OF 2.57 VOLTS. THIS DEVICE IS ON LEGAL HOLD WITHIN THE POST MARKET QUALITY ASSURANCE LABORATORY, AND CANNOT BE TESTED FURTHER. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT, WHO HAS THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), PASSED AWAY. THE PATIENT WAS IN A CAR ACCIDENT. THE PASSENGER SAID THIS PATIENT FELT CHEST PAIN, AND SHORTNESS OF BREATH. THE PATIENT THEN VEERED OFF THE ROAD, AND STRUCK A TREE. THIS PATIENT HAD AN ARRHYTHMIA WHERE THE ATRIAL LEAD UNDERSENSED, AND THE DISCRIMINATORS WERE ONE-BUTTON DETECTION ENHANCEMENT (OBDE). THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) THERAPY, WHICH ACCELERATED THE RHYTHM TO VENTRICULAR FIBRILLATION (VF). THE PATIENT THEN RECEIVED 5 SHOCKS, WHICH EXHAUSTED THERAPY. IT IS UNKNOWN WHETHER THE EPISODE OCCURRED WHILE THE PATIENT WAS DRIVING. THE PATIENT RECEIVED ANOTHER EPISODE WHERE HE RECEIVED 2 ATP. THE CLINICAL ENGINEER AND THE PHYSICIAN HAVE NOT DETERMINED HOW THESE EPISODES OCCURRED. THE DEVICE CLOCK WAS CORRECT WHEN IT WAS INTERROGATED, HOWEVER, THE PATHOLOGIST NOTED THIS PATIENT PASSED AWAY SOMETIME BETWEEN 7 AND 7:30 PM, WHICH WAS BEFORE THE TIME OF THE EPISODES. IT WAS ALSO NOTED THAT EARLIER THAT MORNING (9:36 AM), THIS PATIENT APPROPRIATELY RECEIVED 1 ATP AND A 31 JOULE SHOCK, WHICH SUCCESSFULLY CONVERTED THE VENTRICULAR TACHYCARDIA (VT) ARRHYTHMIA. THE PHYSICIAN HAS REQUESTED A CHEST X-RAY FROM THE AUTOPSY TO SEE IF THE ATRIAL LEAD POSSIBLY DISLODGED FROM THE SHOCK THAT OCCURRED EARLIER THAT MORNING (9:36 AM). A SAVE TO DISK IS ALSO BEING SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) TO BE REVIEWED. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT BSC TS REVIEWED THE SAVE TO DISK, AND DISCUSSED THAT THERE WAS NO THERAPY HISTORY. THE LAST DELIVERED SHOCK WAS AROUND 8:20PM ON THE DAY ((B)(6) 2010) THIS PATIENT PASSED AWAY. ON (B)(6) 2010, IT WAS NOTED THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) PACING IMPEDANCE MEASUREMENTS DOUBLED. THERE WERE NO ADDITIONAL ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death H190| 0185| 4087| 4543