BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1041842 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34805
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 26, 2008
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0863-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED POTENTIAL DIAPHRAGMATIC OVERSENSING AND SUGGESTED TROUBLESHOOTING OPTIONS. AS OF TODAY, THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE WITHOUT ADDITIONAL COMPLICATION. IF ANY ADDITIONAL INFORMATION RELATED TO THIS INCIDENT BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED AND RETURNED FOR RELIABILITY ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD NOISE ON THE RIGHT VENTRICULAR RATE-SENSE AND SHOCK CHANNELS. THE NOISE INHIBITED PACING OF 4 BEATS IN TWO EPISODES. OTHER LEAD MEASUREMENTS ARE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND H210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 0158/172479 WAS IMPLANTED (B)(6) 2007| THE DEVICE 6487 507030 WAS USED DURING THE EVENT.| THE DEVICE 4554/151305 WAS IMPLANTED 16-AUG-2007| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6487 507030 WAS USED DURING THE EVENT.| THE DEVICE 6483 507070 WAS USED DURING THE EVENT.| THE DEVICE 6482 023584 WAS USED DURING THE EVENT.| THE DEVICE 6483 507070 WAS USED DURING THE EVENT.| THE DEVICE 6482 023584 WAS USED DURING THE EVENT.| THE DEVICE 4554/151305 WAS IMPLANTED (B)(6) 2007| THE DEVICE 0158/172479 WAS IMPLANTED 16-AUG-2007