BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1043594 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33047
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 31, 2008
    Report Date
    November 1, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFIBRILLATION LEAD WAS SUCCESSFULLY REVISED. TO DATE, THERE HAVE BEEN NO REPORTED PATIENT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE FOR EVENT CLARIFICATION. THE DEVICE REMAINED IMPLANTED FOR OVER FOUR MORE YEARS, WAS EXPLANTED AND RETURNED FOR ANALYSIS. THE REASON FOR THE EXPLANT WAS UNKNOWN. DETAILED ANALYSIS IS PENDING.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. 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 SPECIFICATIONS 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 ADDITION, LABORATORY TECHNICIANS UTILIZED AN ENGINEERING LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATE THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD DETECTED NOISE WITH ISOMETRICS ON THIS DEFIBRILLATION LEAD. THIS NOISE DID INHIBIT PACING FOR TEN SECONDS AND AN INAPPROPRIATE SHOCK. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES (TS) CONSULTANT AND PHYSICIAN SUSPECTED LEADS REVERSED IN THE HEADER FROM RECENT DEVICE CHANGE OUT PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| O| R THE DEVICE (B)(4) WAS IMPLANTED:| THE DEVICE 4469/300197 WAS IMPLANTED 09-JUL-2001| THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE 4538/151937 WAS IMPLANTED 13-AUG-2004| THE DEVICE (B)(4) WAS IMPLANTED:| THE DEVICE 4312/025498 WAS IMPLANTED 02-AUG-1989| THE DEVICE (B)(4) WAS IMPLANTED:| THE DEVICE (B)(4) WAS IMPLANTED:| THE DEVICE 6481 011615 WAS USED DURING THE EVENT.| THE DEVICE (B)(4) WAS IMPLANTED:| THE DEVICE (B)(4) WAS IMPLANTED:| THE DEVICE (B)(4) WAS IMPLANTED:| THE DEVICE 0063/004899 WAS IMPLANTED 18-JAN-1996| THE DEVICE 4312/026501 WAS IMPLANTED 02-AUG-1989| THE DEVICE 0147/105300 WAS IMPLANTED 09-JUL-2001| THE DEVICE 0040/106399 WAS IMPLANTED 02-AUG-1989| THE DEVICE 0041/111543 WAS IMPLANTED 02-AUG-1989| THE DEVICE (B)(4) WAS IMPLANTED: