BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1954035 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24194
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 24, 2011
    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

    THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, LABORATORY TECHNICIANS UTILIZED AN ENGINEERING LEVEL LONGEVITY PREDICTION CALCULATION 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. REVIEW OF MEMORY CONFIRMED THE DEVICE WAS IN STORAGE MODE DUE TO THE DEPLETED BATTERY. THE TIME BETWEEN ERI AND EOL WAS APPROXIMATELY FIVE MONTHS. PER DEVICE LABELING, THE DEVICE SHOULD BE EXPLANTED NOT MORE THAN 90 DAYS FOLLOWING ERI DECLARATION. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PATIENT IMPLANTED WITH THIS DEVICE ATTENDED A ROUTINE FOLLOW-UP APPOINTMENT ON (B)(6) 2010. THE DEVICE HAD DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2010, AND END OF LIFE (EOL) (B)(6) 2010. THE PATIENT HAD FORGOTTEN TO ATTEND ANOTHER SCHEDULED FOLLOW-UP APPOINTMENT. THE PATIENT IS PACEMAKER DEPENDENT, AND LATER EXPERIENCED SYNCOPE AFTER EOL WAS DECLARED. UPON INTERROGATION, THE DEVICE INDICATED IT WAS IN STORAGE MODE AND COULD NOT BE PROGRAMMED TO MONITOR PLUS THERAPY. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER 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 H195

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R H195