BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2050230 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03077
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 20, 2007
    Report Date
    February 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR BOSTON SCIENTIFIC CRM LABORATORY, 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 PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.S

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) MODEL H135 WAS EXPLANTED BECAUSE OF AN ELECTIVE REPLACEMENT INDICATOR (ERI) THAT WAS DUE TO EXTENDED CHARGE TIME. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS. ANOTHER MODEL GUIDANT CRT-D MODEL H219 WAS SUCCESSFULLY IMPLANTED. NEW INFORMATION RECEIVED INDICATES THAT THE PATIENT HAS RETAINED LEGAL COUNSEL AND FILED A LAWSUIT. THERE WERE NO SPECIFIC ALLEGATIONS AGAINST THE FUNCTIONALITY OF THE DEVICE WITHIN THE CLAIM.

    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 50 YR 6744| 4193| H219| (B)(4)| H135| 1581