BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1874986 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18277
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS CRT-D WAS REMOVED FROM SERVICE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD REACHED A MONITORING VOLTAGE MEASUREMENT OF 2.2 VOLTS. THIS INFORMATION WAS PROVIDED BY THE COMPETITIVE SALES REPRESENTATIVE WHO COULD NOT CONFIRM THE CHARGE TIME MEASUREMNT. THIS COMPETITIVE SALES REPRESENTATIVE INDICATED THAT THIS CRT-D WOULD BE CHANGED OUT SHORTLY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THERE WAS NO ALLEGATION OF PREMATURE BATTERY DEPLETION OR EXPLANT RELATED TO ADVISORY ASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT PUERTO RICO BV H179

    Patients

    Seq Age Sex Outcome Treatment
    1