BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD XT

    MDR report key: 4160084 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02400
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 11, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. 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 NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE ELECTRICAL RESET ALERT WAS TRIGGERED, AND A POWER ON RESET OCCURRED. THE ANALYST NOTED THAT AN ILLEGAL ADDRESS POWER ON RESET (POR) WAS RECORDED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED A POWER ON RESET (POR) AT NOTED VIA A MONITOR TRANSMISSION. THE DEVICE WAS REPROGRAMMED AND 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
    638045 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention