BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2060046 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05927
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FINAL REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES (TS) EXPLAINED THAT THE EPISODE STARTED WITH ATRIAL FIBRILLATION. AS THE EPISODE PROGRESSED, THE ATRIAL FIBRILLATION BECAME STABLE WITH INTRINSIC 1:1 CONDUCTION TO THE VENTRICLE. THE FAST RATE IN THE VENTRICLE FELL WITHIN THE PROGRAMMED PARAMETERS FOR VENTRICULAR TACHYCARDIA, SO THE DEVICE DELIVERED ANTI-TACHYCARDIA PACING (ATP) THERAPY, FOLLOWED BY A SHOCK AND POST-SHOCK PACING. THE ATRIAL FIBRILLATION CONTINUED WITH 1:1 CONDUCTION TO THE VENTRICLE LEADING TO VENTRICULAR TACHYCARDIA, AND A SHOCK WAS DELIVERED. THIS CYCLE HAPPENED AGAIN. TS DISCUSSED THAT WHEN ATRIAL FIBRILLATION OCCURS AND INTRINSIC CONDUCTION IS ABLE TO CONDUCT THE ATRIAL FIBRILLATION FAST ENOUGH TO THE VENTRICLE, THE DEVICE WILL SEE THIS AS A TRUE VENTRICULAR TACHYCARDIA AND WILL DELIVERY THERAPY. TS DETERMINED THAT THE DEVICE WAS WORKING AS DESIGNED AND AS PROGRAMMED. WHILE THE THERAPY WAS CLINICALLY INAPPROPRIATE, IT WAS CONFIRMED BY TS THAT THERE IS NO OPTION TO CHANGE PROGRAMMING TO AVOID THIS SITUATION. THE DEVICE'S THERAPY ZONES WERE REPROGRAMMED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS HOSPITALIZED FOR RECEIVING A STORM OF INAPPROPRIATE SHOCKS DUE TO RHYTHM ACCELERATION. THE RHYTHM ACCELERATION OCCURRED AFTER ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED. SHOCKS WERE DELIVERED UNTIL THERAPY WAS EXHAUSTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. TACHYCARDIA PARAMETERS ON THE DEVICE WERE REPROGRAMMED. A MEMORY DOWNLOAD WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L 4096| T165| 0171