BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1850264 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-14301
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 3, 2010
    Report Date
    January 22, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE AND LEAD SYSTEM REMAIN IN-SERVICE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, VISUAL INSPECTION NOTED THAT THE HEADER WAS FIRMLY ATTACHED TO THE HEADER. ALL OF THE SEAL PLUGS WERE INTACT AND ALL OF THE SETSCREWS OPERATED NORMALLY. THE DEVICE WAS SUCCESSFULLY INTERROGATED AND WAS FOUND WITH A BATTERY STATUS INDICATOR OF END-OF-LIFE (DECLARED ON MARCH 14, 2015) AT 2.16 VOLTS. UTILIZING SPECIALIZED ENGINEERING SOFTWARE, THE END-OF-LIFE STATUS WAS CLEARED AND DUE TO THE LOW BATTERY STATE OF THE DEVICE, A 1.1 JOULE SHOCK WAS PROGRAMMED TO BE DELIVERED. BENCH TESTING CONFIRMED THAT AN APPROPRIATE SHOCK WAS DELIVERERD BY THE DEVICE. IT WAS CONCLUDED THAT THIS DEVICE PERFORMED NORMALLY THROUGHOUT LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT COLLAPSED AT HOME ON (B)(6), 2010. THE LOCAL REPRESENTATIVE WAS CONTACTED ON (B)(6), 2010 TO INTERROGATE THE DEVICE. THE PHYSICIAN REPORTED THAT THE DEVICE DELIVERED SHOCK THERAPY AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. THE PATIENT IS COMATOSE, ON A VENTILATOR FOR RESPIRATORY SUPPORT AND IS SUFFERING FROM HYPOXIC BRAIN SYNDROME. THE EPISODE PRINTOUT WAS SENT TO TECHNICAL SERVICES WHICH SHOWS A SLOW AGONAL VENTRICULAR TACHYCARDIA (VT) THAT ACCELERATED INTO THE PROGRAMMED THERAPY ZONES BUT WAS VARIABLE IN AMPLITUDE AND VECTOR SUCH THAT THE ELECTROGRAM WAS FRAGMENTED WITH PROBABLE UNDERSENSING. THE FIRST PROGRAMMED SHOCK WAS DIVERTED BUT WAS DELIVERED DURING REDETECTION. POST-SHOCK PACING WAS DELIVERED WITH PROBABLE CAPTURE BUT THE ELECTROGRAM REMAINED RELATIVELY FLAT AND SLOW.

    Description of Event or Problem · 1

    (B)(4) RECEIVED INFORMATION THAT THIS DEVICE WAS RECEIVED AT (B)(4) RETURN PRODUCTS DEPARTMENT IN (B)(6) 2015. A MEDICAL RECORDS WEB SEARCH FOUND THAT THIS PATIENT HAD DIED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L 4525| 1861| 4088| H175