BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD XT

    MDR report key: 6006287 · Received October 6, 2016

    Report

    Report Number
    9614453-2016-06029
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    July 4, 2016
    Report Date
    July 26, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TRANSFUSION PROCEDURE, THE PATIENT EXPERIENCED INAPPROPRIATE SHOCK FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO HYPOTENSION. IT WAS NOTED THAT THE DEVICE PROGRAMMING WAS NOT CHANGED AND THE EVENT RESOLVED. THE PATIENT IS A PARTICIPANT IN THE IMPROVE SUDDEN CARDIAC ARREST (SCA) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE INAPPROPRIATE SHOCKS WERE DUE TO THE PROGRAMMING SETTING AND NOT RELATED TO THE DEVICE. IT WAS NOTED THAT DUE TO THE PATIENT¿S UNDERLYING DISEASE OF DILATED CARDIOMYOPATHY, THE VOLUME OVERLOAD TRIGGERED THE MYOCARDIAL DILATION AND ARRHYTHMIA. SO IT WAS POSSIBLE THAT THERE WAS A SHOCK. AS A RESULT, THE DEVICE SETTINGS WERE CHANGED AND THE EVENT RESOLVED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653540 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 5076-52 LEAD, 6935M62 LEAD, 439888 LEAD