BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1944837 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19535
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 4, 2010
    Report Date
    October 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DECLARED END OF LIFE (EOL) DUE TO AN EXTENDED CHARGE TIME OF 33 SECONDS. MONITORING VOLTAGE WAS 2.54 VOLTS. THE PHYSICIAN WONDERED WHY ELECTIVE REPLACEMENT INDICATOR (ERI) HAD NOT BEEN DECLARED. TECHNICAL SERVICES (TS) REVIEWED THE ALERT HISTORY AND DISCUSSED THAT ERI HAD BEEN DECLARED ONE MONTH PRIOR TO EOL BUT THE ALERT WAS NEVER DISMISSED. TS DISCUSSED THAT WE CAN NO LONGER GUARANTEE ALERT MONITORING AND REMOTE INTERROGATIONS OF THIS PATIENT'S DEVICE VIA LATITUDE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H179

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention 4039| H179| 0157