BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1041560 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31977
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    August 27, 2007
    Report Date
    August 27, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED EVALUATING THE LEAD BY PERFORMING A MAXIMUM ENERGY SHOCK. TS ALSO DISCUSSED THAT EITHER A LOW OR HIGH SHOCK IMPEDANCE WOULD CAUSE THE DEVICE TO BEEP. ADDITIONAL INFORMATION WAS PROVIDED THAT A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS PERFORMED TO TEST THE SHOCK SYSTEM INTEGRITY, AND THE SHOCK IMPEDANCE WAS NORMAL ON BOTH THE HIGH AND LOW ENERGY SHOCKS; THE DEVICE WAS FUNCTIONING NORMALLY. TS RECOMMENDED CONTINUED MONITORING OF THE PATIENT AT THAT TIME. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. AS OF TODAY, THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN SERVICE WITHOUT ADDITIONAL COMPLICATION. IF ANY ADDITIONAL INFORMATION RELATED TO THIS INCIDENT BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. IT WAS APPROXIMATELY 6.3 YEARS AFTER EXPLANT IN 2008 THAT THE DEVICE WAS RECEIVED WITH THE LEADS SEVERED AND STILL ATTACHED. THE DEVICE HAD NO TELEMETRY AVAILABLE AND A MEMORY DOWNLOAD WAS UNABLE TO PERFORMED. THE DEVICE HAD NO PACING OUTPUT. HIGH POWER VISUAL INSPECTION NOTED SEVERAL ELECTROCAUTERY MARKS AND CUTS IN THE HEADER. IT WAS DETERMINED THAT THE AS RECEIVED CONDITION OF NO OUTPUT AND NO TELEMETRY WAS DUE TO THE TIME FROM EXPLANT TO RETURN, COMBINED WITH DEVICE STORAGE FOR SIX YEARS WITH SEVERED LEADS ATTACHED TO THE HEADER. IT WAS ELEVEN YEARS FROM IMPLANT TO THE TIME THE DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS DETECTED BY THE LATITUDE SYSTEM FROM THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO A LOW SHOCK IMPEDANCE MEASUREMENT. ADDITIONAL INFORMATION WAS PROVIDED THAT ANOTHER LOW SHOCK IMPEDANCE MEASUREMENT WAS RECORDED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION. IN 2014, THE DEVICE SYSTEM WAS RETURNED FOR ANALYSIS. FURTHER INVESTIGATION WAS DONE AND REVEALED THE PATIENT HAD DIED IN MAY 2008. THERE WERE NO ALLEGATIONS RECEIVED THAT THE DEVICE SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FUNERAL HOME THAT RETURNED THE DEVICE; THE PRIMARY CAUSE OF DEATH WAS CARDIOGENIC SHOCK AND CONGESTIVE HEART FAILURE, AND THE SECONDARY CAUSE WAS LISTED AS ISCHEMIC CARDIOMYOPATHY AND CORONARY ARTERY DISEASE. REPORTEDLY NO AUTOPSY WAS PERFORMED AND THE MANNER OF DEATH WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4243/313557 WAS IMPLANTED 16-MAR-1999| THE DEVICE 0125/316838 WAS IMPLANTED (B)(6) 1999| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6481 013257 WAS USED DURING THE EVENT.| THE DEVICE 4513/400236 WAS IMPLANTED 20-AUG-2003| THE DEVICE 0125/316838 WAS IMPLANTED 16-MAR-1999| THE DEVICE 6481 013257 WAS USED DURING THE EVENT.| THE DEVICE 4243/313557 WAS IMPLANTED (B)(6) 1999| THE DEVICE 4513/400236 WAS IMPLANTED (B)(6) 2003