BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD XT

    MDR report key: 3860071 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01203
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT OCCURRED OUTSIDE THE US AND IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCTS: 439888 LEAD IMPLANTED: 2014 (B)(6); 5554-53 LEAD IMPLANTED: 2014 (B)(6). (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 A POWER ON RESET (POR) OCCURRED. ANALYST COMMENTED, POR OCCURRED ON (B)(6) 2014.

    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 THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ENCOUNTERED A POWER ON RESET. THE PATIENT WAS HOSPITALIZED. THE DEVICE REMAINS IN USE, HOWEVER, THERE IS PLANNED INTERVENTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339363 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R 6947M62 LEAD