BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2170249 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09344
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 30, 2011
    Report Date
    August 26, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INFORMATION KNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, INTERROGATION REVEALED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE RESULTS OF A LONGEVITY CALCULATION 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 SPECIFICATION TRIGGERED ERI EARLIER THAN EXPECTED. DEVICE CIRCUITRY WAS DESIGNED SUCH THAT THE ERI CHARGE TIME LIMIT OF 18 SECONDS WOULD BE REACHED NEAR THE CORRESPONDING ERI MONITORING VOLTAGE LIMIT. ENGINEERS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE A COMPONENT FAILURE OR PREMATURE BATTERY DEPLETION. RATHER, THE REPLACEMENT INDICATOR WAS DECLARED DUE TO A BUILD-UP OF INTERNAL BATTERY IMPEDANCE, PREVENTING THE DEVICE FROM MEETING ITS EXPECTED LONGEVITY PER DEVICE LABELING.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHETHER THIS DEVICE WILL BE RETURNED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY (CRT-D) DEVICE DISPLAYED ELECTIVE REPLACEMENT INDICATORS WITHIN THIRTY MONTHS OF IMPLANT. A FAMILY MEMBER OF THE PATIENT WITH THIS DEVICE CONTACTED AN INTERNAL TECHNICAL SERVICE CONSULTANT REGARDING THIS ISSUE AND WAS REFERRED TO THE PATIENT'S PHYSICIAN. REPORTEDLY, A REPLACEMENT PROCEDURE IS INTENDED IN THE NEAR FUTURE. 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 Required Intervention