BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2041493 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00830
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED THIS DEVICE AT THEIR POST MARKET QUALITY ASSURANCE LABORATORY FOR A ROUTINE ASSESSMENT POST EXPLANT. NO PERFORMANCE OR LONGEVITY ALLEGATIONS COMMUNICATED WITH THE RETURNED PRODUCT. ADDITIONALLY, NO ADVERSE PATIENT EFFECTS 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 68 YR H155| 4096| 0185| N119