BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD XT

    MDR report key: 4162610 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02513
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT OF A DEVICE, THE RIGHT VENTRICULAR (RV) COMPETITOR LEAD WHICH WAS PREVIOUSLY IMPLANTED WAS UNABLE TO BE INSERTED ENTIRELY INTO THE RV CHANNEL OF THE DEVICE. LOSS OF PACING OCCURRED DUE TO HIGH IMPEDANCES, RESULTING IN THE PATIENT DEVELOPING ASYSTOLE. THE RV LEAD WAS THEN PUSHED MANY TIMES INTO THE RV CHANNEL, WITH THE SAME RESULT. THE PHYSICIAN CHOSE TO IMPLANT A COMPETITOR DEVICE DUE TO DOUBTS ABOUT THE COMPATIBILITY BETWEEN CONNECTORS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643816 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1