BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2163414 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07971
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 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 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 ERI CHARGE TIME LIMIT SPECIFIED IN DEVICE LABELING. DEVICE CIRCUITRY WAS DESIGNED SUCH THAT THE ERI CHARGE TIME LIMIT 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 DECLARE 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 DEVICE WAS EXPLANTED AND RETURNED. THERE WAS NO ALLEGATION FROM THE FIELD REGARDING THE FUNCTION OF THE DEVICE. INITIAL TESTING NOTED A POSSIBLE PERFORMANCE ISSUE CONCERNING BATTERY LONGEVITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 83 YR 1851| 4470| 4517| H155| H195| 0148