BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 783429 · Received November 9, 2006

    Report

    Report Number
    2124215-2006-17290
    Event Type
    Malfunction
    Date Received
    November 9, 2006
    Date of Event
    July 13, 2006
    Report Date
    August 2, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT, 52.8 MONTHS POST-IMPLANT, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED AN ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS THUS EXPLANTED. IT WAS ALSO REPORTED THAT THIS PARTICULAR MODEL/SERIAL DEVICE IS IMPACTED BY THE PHYSICIAN COMMUNICATION ISSUED ON JUNE 17, 2005 FOR THIS MODEL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR LWS CARDIAC PACEMAKERS, INC H135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other