BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1953805 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24215
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    November 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND REPLACED 8.2 MONTHS LATER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED OR IF THE DEVICE IS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. A LONGEVITY CALCULATION WAS PERFORMED, AND IT WAS DETERMINED THAT THE DEVICE HAD MET SPECIFICATION AND EXHIBITED BEHAVIOR OF NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS ASSOCIATED WITH A BATTERY MEASUREMENT OF 2.55 VOLTS AFTER 57.7 MONTHS OF IMPLANT. THIS DEVICE IS INCLUDED IN THE (B)(6) 2007 SHORTENED REPLACEMENT WINDOW ADVISORY POPULATION. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED THAT IT WAS NOT IMMEDIATELY KNOWN IF THIS DEVICE WAS MEETING THE DEFINITION OF PREMATURE BATTERY DEPLETION, ACCORDING TO THE ADVISORY CRITERIA, BASED ON THE AVAILABLE VOLTAGE MEASUREMENT AND IMPLANT TIME. TS RECOMMENDED MONTHLY DEVICE FOLLOW-UPS, WITH REPLACEMENT WITHIN 30 DAYS WHEN ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS IS REACHED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other 0157| 4469| 4512| H219