BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1861005 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15057
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC, CRM WILL ANALYZE THIS DEVICE UPON RECEIPT AND PROVIDE ADDITIONAL INFORMATION ONCE THE TESTING HAS BEEN COMPLETED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL INTERROGATION REVEALED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). OUR TECHNICIANS COMPARED THE OBSERVED RATE OF BATTERY USAGE TO THE EXPECTED RATE OF BATTERY USAGE. THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, TWO CONSECUTIVE CHARGE TIMES IN EXCESS OF THE 18 SECOND SPECIFICATION TRIGGERED ERI EARLIER THAN EXPECTED. ENGINEERS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE A COMPONENT FAILURE OR PREMATURE BATTERY DEPLETION. RATHER, THE ERI CHARGE TIME INDICATOR WAS DECLARED DUE TO A BUILD-UP OF INTERNAL BATTERY IMPEDANCE, PREVENTING THE DEVICE FROM MEETING ITS EXPECTED LONGEVITY PER DEVICE LABELING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS 3-YEAR-OLD CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED AFTER THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS. ALSO, THE PHYSICIAN WAS DISSATISFIED WITH DEVICE 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