BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1954208 · Received January 10, 2011

    Report

    Report Number
    2124215-2011-00270
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE.AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE ALERT WAS ISSUED FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO TACHY MODE BEING SET TO OTHER THAN MONITOR+THERAPY. THE LOCAL ARE SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. IT WAS DISCOVERED THE DEVICE HAD BEEN INADVERTENTLY PROGRAMMED TO OTHER THAN MONITOR+THERAPY AT A ROUTINE FOLLOW-UP. THE PATIENT WAS BROUGHT BACK INTO CLINIC AND THE DEVICE WAS PROGRAMMED BACK TO MONITOR+THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 0185| 4470| 4518| H219