BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2041738 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01104
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    April 27, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD THEIR DEVICE CHECKED AND IT WAS FOUND TO BE IN STORAGE MODE SINCE (B)(6) 2009. TECHNICAL SERVICES (TS) DISCUSSED THAT NO THERAPY IS AVAILABLE, IT WAS REPORTED THAT THE PATIENT WAS AT THE HOSPITAL AND A DEVICE CHANGE OUT WAS TO OCCUR IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, WE ARE UNABLE TO DETERMINE WHETHER THIS PRODUCT MET MINIMUM LONGEVITY EXPECTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 4537| 0158| 4470| H177