BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1951048 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23682
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 19, 2010
    Report Date
    December 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD INDICATING THE DEVICE HAD BEEN PROGRAMMED TO OFF FOR A SURGICAL PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL PRIOR TO THE DEVICE BEING PROGRAMMED BACK TO MONITOR + THERAPY. THE PATIENT WAS BROUGHT BACK INTO THE HOSPITAL AND THE DEVICE WAS PROGRAMMED BACK TO MONITOR + THERAPY. THERE WERE NO ADVERSE PATIENT EFFECTS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    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 THE DEVICE BEING SET TO TACHY MODE OTHER THAN MONITOR PLUS 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 H210

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 4538| 4473| H210| 0157