BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD XT

    MDR report key: 3991329 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01712
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. CONCOMITANT: 5076-52 LEAD, IMPLANTED: 2014-(B)(6); 694765 LEAD, IMPLANTED: 2014-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT FOR HIGH IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. AN X-RAY CONFIRMED THAT THERE WAS A LEAD CONNECTION ISSUE AS THE LEAD WAS NOT INSERTED FAR ENOUGH INTO THE HEADER OF THE DEVICE. THE LEAD AND DEVICE REMAIN 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
    472222 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2Q1

    Patients

    Seq Age Sex Outcome Treatment
    1 4598 LEAD