BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1952224 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23489
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 2, 2010
    Report Date
    September 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED OR IF THE DEVICE IS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE ICD WAS PERFORMED. A REVIEW OF THE MEMORY REVEALED THAT THE HAD DEVICE REACHED END OF LIFE/BATTERY EXPIRED AND SUBSEQUENTLY REVERTED TO STORAGE MODE ON (B)(6) 2010. THE PATIENT'S HOSPITALIZATION AND THE INFORMATION THAT THE DEVICE FAILED TO DELIVERY THERAPY WAS REPORTED NINE MONTHS LATER. IT WAS ALSO CONFIRMED THROUGH A FIRMWARE PATCH THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2010, THREE MONTHS PRIOR TO THE PATIENT'S DEATH. LABORATORY TECHNICIANS USED 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 INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. BECAUSE OF THE LOW BATTERY VOLTAGE, DIAGNOSTIC TESTING COULD NOT BE CONDUCTED TO VERIFY THE PERFORMANCE OF THERAPY DELIVERY, SENSING, AND RECORDING FUNCTIONS. FURTHER REVIEW OF THE DEVICE MEMORY REVEALED THAT PRIOR TO REVERTING TO STORAGE MODE, THE DEVICE RECORDED STABLE LEAD IMPEDANCE MEASUREMENTS AND WAS ABLE TO PROVIDE THERAPY. LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE HAD MET SPECIFICATIONS DURING TESTING AND EXPERIENCED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT WITH THIS ICD DIED THREE MONTHS FOLLOWING THE REPORTED HOSPITALIZATION AND THE DISCOVERY THAT THE ICD WAS IN STORAGE MODE. THERE WERE NO FURTHER ALLEGATIONS MADE AGAINST THE FUNCTIONALITY OF THE DEVICE OR THAT IT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE ICD WAS LATER RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A HEALTH CARE PROVIDER (HCP) THAT THIS DEVICE WAS FOUND TO BE IN STORAGE MODE WHEN THE PATIENT WAS ADMITTED TO A HOSPITAL. HCP REPORTED THE PATIENT HAD AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) THAT WAS NOT TREATED BY THE DEVICE, AND THERE WAS NO EVIDENCE OF PACING ON A SURFACE ELECTROCARDIOGRAM. THE DEVICE WAS TO BE REPLACED. NO OTHER DETAILS WERE IMMEDIATELY AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS INCLUDED IN THE NOVEMBER 27, 2007 MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R 0157| 4087| H170| 4537