BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2053501 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03953
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    May 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DEVICE RETURN AND ANALYSIS THIS INVESTIGAITON WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN EXPLANTED AND WILL BE RETURNED. UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR LABORATORY, DEVICE INTERROGATION REVEALED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). A LONGEVITY CALCULATION USING THE MOST RECENT PROGRAMMED PARAMETERS AND THERAPY USE INFORMATION INDICATED THAT THE DEVICE FELL SHORT OF LABELED LONGEVITY EXPECTATIONS. REVIEW OF SELF-DIAGNOSTIC TEST RESULTS STORED IN DEVICE MEMORY DID NOT IDENTIFY ANY PERIODS OF EXCESSIVE CURRENT OR ENERGY USE DURING THE LIFE OF THE DEVICE. PRELIMINARY TESTING OF DEVICE FUNCTION DEMONSTRATED NORMAL BEHAVIOR. FURTHER ANALYSIS OF DEVICE MEMORY INDICATED THAT AN ERI INDICATOR WAS DECLARED DUE TO TWO CONSECUTIVE CHARGES EXCEEDING THE ERI CHARGE TIME LIMIT. THE MONITORING VOLTAGE WAS ABOVE THE ERI LIMIT, INDICATING THAT THE BATTERY WAS NOT DEPLETED AND HAD SUFFICIENT CAPACITY REMAINING TO PROVIDE THERAPY IF NEEDED. HOWEVER, THE CHARGE TIMES WOULD HAVE BEEN LONGER THAN THE 18 SECONDS ERI CHARGE TIME LIMIT SPECIFIED IN DEVICE LABELING. DEVICE CIRCUITRY WAS DESIGNED SUCH THAT THE ERI CHARGE TIME LIMIT OF 18 SECONDS WOULD BE REACHED NEAR THE CORRESPONDING ERI MONITORING VOLTAGE LIMIT. IN THIS CASE, A NORMAL BUT EARLIER THAN EXPECTED BUILDUP OF INTERNAL BATTERY IMPEDANCE INCREASED CHARGE TIME, CAUSING THE CHARGE TIME INDICATOR TO TRIP ERI EARLY. DESPITE THE LONGEVITY SHORTFALL, REPLACEMENT INDICATORS OPERATED AS DESIGNED AND THE DEVICE WAS CAPABLE OF DETECTING AND TREATING ARRHYTHMIAS FOR SEVERAL ADDITIONAL MONTHS AS DESCRIBED IN DEVICE LABELING. THIS ENSURED PATIENT SAFETY DURING THE REPLACEMENT PERIOD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WILL BE EXPLANTED AND REPLACED. PREMATURE BATTERY DEPLETION WAS ALLEGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H155

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention