BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD S

    MDR report key: 3861592 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01759
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE TIME OF THE IMPLANT THE CONNECTION OF THE SHOCK COMPETITOR LEAD WAS NOT INSERTED CORRECTLY AND THE LEAD SHOWED ABNORMAL IMPEDANCE VALUE. THE RIGHT VENTRICULAR (RV) LEAD WAS DETACHED AT ONCE AND RECONNECTED. AT THE TIME OF THE RECONNECTION STRONG RESISTANCE WAS FELT AND THEY WERE UNABLE TO INSERT THE LEAD DEEPLY. THERE WAS HIGH RV LEAD IMPEDANCE AND ABNORMAL SENSING. THE CONNECTION WAS ACCOMPLISHED AFTER A SILICON OIL WAS APPLIED. THE OPERATION WAS COMPLETED WITHOUT INCIDENT. 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
    342299 VIVA QUAD S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC, INC. DTBB2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1