BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2060031 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05692
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    May 5, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED THAT THE RV+ AND RA+ SEAL PLUGS WERE MISSING. THE MEDICAL ADHESIVE COVERING THE RV- HEADER WIRE TO THE RV- CONNECTOR BLOCK WAS ALSO MISSING. THE RV+ AND RA+ SETSCREWS WERE STUCK IN THE UP POSITION. ALL OTHER SETSCREWS MOVED FREELY. LABORATORY TECHNICIANS THEN LOOSENED THE STUCK SETSCREWS. POST-DECONTAMINATION MICROSCOPIC VISUAL INSPECTION NOTED THAT THE RA+ RETAINER RING WAS BENT UPWARD. A LEAD WAS INSERTED INTO EACH LEAD BARREL AND EACH SETSCREW TIGHTENED ON THE LEAD PIN WITHOUT DIFFICULTIES AND THE LEAD REMAINED IN PLACE WHEN MODERATE TO STRONG FORCE WAS APPLIED. 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. LABORATORY TESTING CONFIRMED THE STUCK SETSCREWS, AND DETERMINED THAT THE LEADS APPEARING TO BE STUCK IN THE DEVICE HEADER WAS LIKELY CAUSED BY NOT LOOSENING ALL OF THE SETSCREWS. THE CAUSE OF THE STUCK SETSCREWS AND BENT RETAINER RING WERE CONSISTENT WITH INDUCED DAMAGE.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE NORMAL REPLACEMENT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ELECTIVE REPLACEMENT INDICATOR (ERI), THE PHYSICIAN THOUGHT THE SETSCREWS WERE STUCK, AS THEY COULD NOT REMOVE THE LEADS FROM THE HEADER. IT WAS FOUND TO BE DUE TO THE PHYSICIAN HAD NOT LOOSENED ALL THE SETSCREWS. ONCE LOOSENED, THE LEADS WERE ABLE TO BE SUCCESSFULLY REMOVED. 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 H170

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR H170| 5592| 4542| 0184| N119