BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2041696 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00989
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS WAS DECLARED AFTER EXPERIENCING TWO CHARGE TIMES GREATER THAN THE CHARGE TIME LIMIT. END OF LIFE (EOL) STATUS WAS DECLARED FOLLOWING A SINGLE CHARGE TIME GREATER THAN 30 SECONDS. TO DETERMINE IF THE DEVICE'S RATE OF BATTERY DEPLETION WAS WITHIN NORMAL LIMITS, OUR TECHNICIANS COMPARED THE OBSERVED RATE OF BATTERY USAGE TO THE EXPECTED RATE OF BATTERY USAGE. THE RESULTS SHOWED THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. LABORATORY TECHNICIANS AND ENGINEERS CONCLUDED THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, THE ERI TO EOL TIME PERIOD WAS SHORTENED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THE DEVICE WAS CAPABLE OF DETECTING AND TREATING ARRHYTHMIAS, AS THE BATTERY ITSELF HAD SUFFICIENT CAPACITY REMAINING TO PROVIDE THERAPY IF NEEDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE EXHIBITED AN EXTENDED CHARGE TIME WITHIN SPECIFICATION WHILE IMPLANTED. THE DEVICE REMAINED IN SERVICE, AND WAS EXPLANTED 14.7 MONTHS LATER FOR NORMAL BATTERY DEPLETION WITH NO SUBSEQUENT ISSUES OR ADVERSE PATIENT EFFECTS REPORTED. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION INITIALLY COMMUNICATED (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H179

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 0155| 4054| H179