BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2040702 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00517
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    August 10, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE REMAINS IMPLANTED NO ANALYSIS WILL BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED NOTED THAT THIS DEVICE WAS EXPLANTED AS IT WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION WAS COMPLETED TO ASSESS THE RATE OF BATTERY DEPLETION. GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE, THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, DEFIBRILLATION, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION. THE DEVICE DID NOT DECLARE ERI OR EOL WHILE IMPLANTED AND THE CURRENT CALCULATION INDICATES THE DEVICE CURRENT WAS NORMAL (NO PREMATURE DEPLETION). THE HIGH LV THRESHOLD IS A PATIENT / LEAD ISSUE NOT A DEVICE ISSUE. DEVICE WAS CONFIRMED TO BE FUNCTIONING NORMAL.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ALLEGED TO DEPLETE PREMATURELY DESPITE ELEVATED LEFT VENTRICULAR THRESHOLDS. A FOLLOW UP HAS BEEN SCHEDULED. AT THIS TIME THE DEVICE REMAINS IMPLANTED AND 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 M170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R