BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1861138 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15532
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 17, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0949-05 THRU Z-0953-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HEADER WAS EXAMINED. VISUAL INSPECTION NOTED THAT A WRENCH TIP WAS BROKEN OFF IN THE UP POSITION IN THE RIGHT VENTRICULAR HEX SLOT. FURTHER MICROSCOPIC ANALYSIS NOTED THAT THE DISTAL ATRIAL SETSCREW WAS STUCK IN THE UP POSITION AND ITS RETAINER CAP WAS BENT. THE SETSCREWS WERE REMOVED FROM THE CONNECTOR BLOCK AND NO IRREGULARITIES IN THE SETSCREW THREADS OR IN THE THREADS OF THE CONNECTOR BLOCK WERE REVEALED. TECHNICIANS EXPOSED THE DEVICE TO SIMULATED HEART LOAD CONDITIONS, AND THEN TESTED THE PACING AND SENSING FUNCTIONS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF DETAILED TESTS WERE ALSO PERFORMED TO MEASURE THE ELECTRICAL PERFORMANCE OF THE DEVICE. NORMAL FUNCTION WAS OBSERVED AND THE PACEMAKER DID NOT EXHIBIT ANY ANOMALIES. THE DAMAGE TO THE RIGHT ATRIAL RETAINER RING AND BROKEN TORQUE WRENCH TIP WAS INADVERTENTLY INDUCED.

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ELECTIVE REPLACEMENT OF THIS CARDIAC RESYCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE TORQUE WRENCH GOT STUCK INSIDE THE HEADER WHEN ATTEMPTING TO LOOSEN THE RIGHT VENTRICULAR LEAD SETSCREW. THE PHYSICIAN ELECTED TO CUT THE RIGHT VENTRICULAR (RV) LEAD PACE/SENSE PORTION AND IMPLANTED A COMPETITOR LEAD. DURING THE SAME EXPLANT PROCEDURE IT WAS ALSO NOT POSSIBLE TO LOOSEN THE SETSCREWS OF THE RIGHT ATRIAL LEAD PORT. THE RIGHT ATRIAL (RA) LEAD WAS ALSO CUT AND CAPPED. AT THIS TIME NO ATRIAL LEAD IS IMPLANTED. THE DEVICE WAS RETURNED FOR ANALYSIS. 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 H195

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR