BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1944788 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19792
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 7, 2010
    Report Date
    December 21, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS PERFORMED. VENTRICULAR TACHYCARDIA WAS INDUCED INTO THE VF ZONE AND THIS WAS SUCCESSFULLY CONVERTED WITH A 41 JOULE SHOCK. IN ADDITION, THE ATRIAL FIBRILLATION RATE THRESHOLD WAS TURNED OFF AS A POST SHOCK DETECTION ENHANCEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RETURN TO OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE UNDERWENT DETAILED ANALYSIS. EXTERNAL VISUAL INSPECTION NOTED BODY FLUID CONTAMINATION IN THE LEAD BARRELS. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONISM 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. IN CONCLUSION, LAB ANALYSIS COULD NOT CONFIRM THE FIELD OBSERVATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS LATER EXPLANTED FOR NORMAL BATTERY DEPLETION AND RETURNED FOR ANALYSIS. DETAILED ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED UNNECESSARY SHOCKS FOR SINUS/ATRIAL TACHYCARDIA TO THERAPY EXHAUSTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H217

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 0064| 4543| H217| 1861| 0125| 4271| 1810