BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD XT

    MDR report key: 3990387 · Received August 7, 2014

    Report

    Report Number
    6000094-2014-00011
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 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 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. THERE WAS AN ILLEGAL ADDRESS POWER ON RESET (POR) ON (B)(4) 2014 CAUSING A FALSE LOW BATTERY VOLTAGE MEASUREMENT.

    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 PATIENT HAD NOTICED AN ALERT SOUND THREE TIMES AND CAME TO THE HOSPITAL. THE MEDICAL ENGINEER (ME) CHECKED THE DEVICE AND FOUND THAT IT HAD BEEN RESET. THE ME REPORTED THAT THERE WAS NO ISSUE WITH THE DATA EXCEPT THAT THE REMAINING BATTERY LIFE HAD BEEN INITIALIZED. THE ME WAS CONCERNED THAT ATRIAL TACHYCARDIA HAD OCCURRED AT EXACTLY THE SAME TIME AS THE RESET. THE ATRIAL TACHYCARDIA WAS REPORTED TO BE STILL CONTINUING. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464196 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R 6947M62 LEAD, 439878 LEAD