BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD S

    MDR report key: 3990507 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01789
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT 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. CONCOMITANT PRODUCT: ST. JUDE LEAD IMPLANTED: (B)(6) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY CONNECTING THE LEFT VENTRICULAR (LV) LEAD AND THE DEVICE. THE CONNECTION WAS CONFIRMED AND THE IMPEDANCE MEASURED WITH THE PROGRAMMER. A FEW HOURS LATER, TESTING WITH THE PROGRAMMER REVEALED HIGH IMPEDANCE WITH THE LV LEAD. THE PHYSICIAN DISCONNECTED AND RECONNECTED THE LV LEAD INTO THE DEVICE. THE LV IMPEDANCE WAS WITHIN NORMAL RANGE. THE READINGS BETWEEN THE DEVICE AND THE PROGRAMMER DIFFERED. THE LV LEAD AGAIN WAS DISCONNECTED AND RECONNECTED DUE TO HIGH IMPEDANCE. THE PHYSICIAN DECIDED TO USE A DIFFERENT DEVICE DUE TO CONCERNS WITH THE CONNECTION AND BATTERY ON THE DEVICE. THE LV LEAD REMAINS IMPLANTED ALONG WITH THE NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468568 VIVA QUAD S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBB2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 439888, LEAD