BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVIAN

    MDR report key: 3210967 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08561
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WITH OVERSENSING WHICH CAUSED PACING INHIBITION. ALSO, NON-SUSTAINED VENTRICULAR TACHYCARDIA EVENTS WERE STORED DUE TO THIS ISSUE. THERE HAS BEEN NO INAPPROPRIATE TACHY THERAPY DELIVERY, HOWEVER, AT THE RECENT EVALUATION TACHY THERAPY WAS TURNED OFF BECAUSE OF THE OBSERVATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED TO THE HEALTH CARE PROFESSIONAL (HCP) PROGRAMMING THE RV SENSITIVITY TO THE LEAST SENSITIVITY TO MITIGATE ANY PACING ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE SYSTEM CURRENTLY REMAINS IN SERVICE, BUT A REVISION PROCEDURE WAS SCHEDULED TO BE DONE IN A COUPLE OF MONTHS. IT WAS REPORTED THAT THE PHYSICIAN WAS NOT PLANNING ON USING BOSTON SCIENTIFIC AT THE PROCEDURE. THE FIELD REPRESENTATIVE WAS NOT ABLE TO OBTAIN ANY ADDITIONAL INFORMATION RELATED TO PATIENT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310512 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR H220| 2187| 6943| 6940| 1235| MISMATCH