BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2073535 · Received May 2, 2011

    Report

    Report Number
    2124215-2011-07616
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE ANY ADDITIONAL INFORMATION IS AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED SEVERAL EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIAS (NSVT) DUE TO NOISE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. NO SHOCKS WERE DELIVERED BUT THE OVERSENSING RESULTED IN PACING INHIBITION FOR MORE THAN TWO SECONDS. THE PATIENT REPORTED NO ADVERSE EFFECTS DURING THE TIMES OF THESE EPISODES AND WAS IN NORMAL SINUS RHYTHM DURING THE FOLLOW UP VISIT. THE CRT-D WAS REPROGRAMMED SO THAT THE DURATION WAS LENGTHENED AND IT REMAINS IMPLANTED AND IN SERVICE. A SAVE TO DISK WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H230

    Patients

    Seq Age Sex Outcome Treatment
    1 H230| 4555| 4470| 0158