BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1945004 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-24414
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS CRT-D HAS SINCE BEEN REMOVED FROM SERVICE AS A RESULT OF NORMAL BATTERY DEPLETION. THE RV RATE SENSE REMAINS ACTIVELY IN SERVICE. A BACK UP RV PACING LEAD WAS ADDED TO THE SYSTEM FOR USE AS NEEDED IN THE FUTURE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFICI CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IN ASSOCIATION WITH THE RIGHT VENTRICULAR RATE/SENSE LEAD PORTION, DID EXHIBIT NOISE OVERSENSING WHICH LED TO PACEMAKER INHIBITION FOR THIS PACEMAKER DEPENDENT PATIENT. THERE WERE ANY ADVERSE PATIENT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 0185| H175| 4513