BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL

    MDR report key: 659227 · Received November 14, 2005

    Report

    Report Number
    2124215-2005-10766
    Event Type
    Death
    Date Received
    November 14, 2005
    Date of Event
    July 7, 2005
    Report Date
    July 7, 2005
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEAD SYSTEM EXHIBITED PACING IMPEDANCES OF GREATER THAN 2000 OHMS ON THE RIGHT AND LEFT VENTRICULAR LEADS. STORED ELECTROGRAMS SHOWED EPISODES OF OVERSENSING. A GUIDANT TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THAT THE OVERSENSING COULD BE MYOPOTENTIALS OR A SETSCREW ISSUE. SENSITIVITY HAD BEEN REPROGRAMMED TO LEAST TO REMEDY THE OVERSENSING. TS ALSO DISCUSSED THAT THE INCREASE IN PACING IMPEDANCE COULD BE DUE TO A LEAD ISSUE ON THE DEFIBRILLATION LEAD, OR A MYOCARDIAL INFARCTION OR TISSUE CHANGE WITHIN THE PATIENT. THE DEVICE WAS REPROGRAMMED TO DDI MODE AND THE AV DELAY WAS SET TO 300MS, DUE TO THE PATIENT'S WORSENING CONDITION. LATER, THE DEVICE WAS DEACTIVATED AS THE PATIENT WAS NOT EXPECTED TO SURVIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death