BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD XT

    MDR report key: 3861823 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01415
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 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 UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (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 POWER ON RESET (POR) PARAMETERS WERE PRESENT, AND THE ELECTRICAL RESET ALERT TRIGGERED. A POR WAS RECORDED ON (B)(6) 2014: FIRMWARE INITIATED A SCHEDULER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO CLOSING THE POCKET THE DEVICE WAS TESTED AND THE TELEMETRY CONNECTION WAS LOST AND A RESET MESSAGE OCCURRED. THE BATTERY VOLTAGE WAS 2.87V, AND THE INDICATOR DISPLAYED GRAY. THE DEVICE WAS LEFT IMPLANTED AND THE PATIENT CONTINUED TO BE OBSERVED IN THE HOSPITAL. THREE DAYS LATER THE BATTERY VOLTAGE WAS 3.07V AND THE INDICATOR REMAINED GRAY. IT WAS DETERMINED THAT THE POWER ON RESET (POR) WAS DUE TO AN UNEXPECTED TIMING INTERACTION WITHIN THE DEVICE FIRMWARE THAT OCCURRED DURING THE TEST. THE ISSUE CAN ONLY OCCUR IF ONE BEGINS AND THEN ABORTS A MANUAL TEST WITHIN A SPECIFIC 20 SECOND WINDOW 30 MINUTES AFTER IMPLANT HAS BEEN COMPLETED. WHEN A DEVICE CHECK WAS PERFORMED ONE WEEK AFTER IMPLANT THE BATTERY INDICATOR HAD RECOVERED FROM GRAY TO GREEN AND THE DEVICE WAS FUNCTIONING PROPERLY. THE DEVICE IS STILL 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
    340417 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R