BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1950775 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22570
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TWO DAYS POST IMPLANT, THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY (CRT-D) DEVICE EXPERIENCED AN INAPPROPRIATE SHOCK. IN ADDITION, OVERSENSING CAUSING PACING INHIBITION WAS REVEALED. THE NOISE COULD BE REPRODUCED. IT WAS DETERMINED THERE WAS A RIGHT VENTRICULAR LEAD ISSUE, A REVISION PROCEDURE WAS PERFORMED, THE RIGHT VENTRICULAR LEAD WAS REPOSITIONED RESOLVING THE ISSUE. NO FURTHER PATIENT SYMPTOMS WERE REVEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H197

    Patients

    Seq Age Sex Outcome Treatment
    1 Other