BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 815756 · Received February 8, 2007

    Report

    Report Number
    2124215-2007-20237
    Event Type
    Malfunction
    Date Received
    February 8, 2007
    Date of Event
    December 1, 2006
    Report Date
    December 22, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z0907/8-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMALLY GUIDANT) RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPLACED AS IT REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI). ON JUNE 17, 2005, GUIDANT (NOW BOSTON SCIENTIFIC) ISSUED A NOTIFICATION LETTER TO PHYSICIANS ON THIS DEVICE MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR LWS CARDIAC PACEMAKERS, INC H155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other