BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1952569 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23328
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION. THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H135

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)