BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1944797 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-21022
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 6, 2010
    Report Date
    June 15, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS CONFIRMED THERE WAS A HOLE IN THE VRING SEALPLUG, WHICH MAY HAVE CONTRIBUTED TO THE INITIAL ALLEGATION OF NOISE/OVERSENSING. THIS CRT-D PASSED TESTING, WHICH VERIFIED PACING, SENSING, DEFIBRILLATION AND RECORDING FUNCTIONS.

    Additional Manufacturer Narrative · 1

    THIS CRT-D REMAINS IN SERVICE, SO THEREFORE WILL NOT 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.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THIS CRT-D WAS RETURNED TO BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING INTERROGATION AT A FOLLOW-UP PROCEDURE, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISY SIGNALS. THE PHYSICIAN ELECTED TO REPROGRAM THE SENSITIVITY TO LEAST, AND INCREASED THE VENTRICULAR FIBRILLATION (VF) DETECTION. A SAVE TO DISK WAS SENT INTO BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) TO BE REVIEWED. BSC TS DISCUSSED THAT THE INTRINSIC AMPLITUDE OVER THE PAST YEAR WAS 3 MV AND THE RIGHT VENTRICULAR (RV) PACE IMPEDANCE WAS 750 OHMS. THERE WERE THREE VENTRICULAR FIBRILLATION (VF) EPISODES, WHICH WERE ALL DIVERT/RECONFIRM EPISODES. ALL THE EPISODES SHOW NOISE ON THE RV RATE/SENSE CHANNEL, AND ALL EPISODES SHOW PACING INHIBITION BETWEEN 1 TO 7 SECONDS. THIS PATIENT HAD REPORTED TO HIS PHYSICIAN THAT HE FELT DIZZY AND SYMPTOMATIC. THE NOISE WAS CONSISTENT WITH DIAPHRAGMATIC OVERSENSING. BSC TS AGREED WITH THE TEMPORARY REPROGRAMMING OF LEAST SENSITIVE IN THE RV. BSC TS ALSO DISCUSSED SOME TROUBLE SHOOTING IDEAS REGARDING RECREATING NOISE. BSC TS NOTED THERE WERE NO INDICATIONS OF FURTHER COMPROMISE. THE LEAD IMPEDANCE (PACE/SHOCK), THRESHOLDS AND INTRINSIC AMPLITUDE WERE STABLE OVER THE PAST YEAR. PATIENT MIGHT BE GIVEN THE OPTION FOR A REPLACEMENT PROCEDURE IN THE NEAR FUTURE. THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H199

    Patients

    Seq Age Sex Outcome Treatment
    1