BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD XT

    MDR report key: 6008228 · Received October 6, 2016

    Report

    Report Number
    9614453-2016-06303
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    December 1, 2014
    Report Date
    August 5, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 DURING THE FIRST RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENTS THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)ȁD HIGH IMPEDANCE MEASUREMENTS ON THE RV DEFIBRILLATION COIL SUSPECTED AS NOT WELL CONNECTED TO ICD. THE ICD AND RV LEAD 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
    659198 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 6935M62 LEAD