BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 6005440 · Received October 6, 2016

    Report

    Report Number
    9614453-2016-05896
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 21, 2016
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 IMPEDANCE ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ON (B)(4) 2016 RV COIL IMPEDANCE ROSE TO 84 OHMS AND THEN TO 146 OHMS ON (B)(4) 2016 UP FROM A TREND OF 43-72 OHMS. THEN VARIED FROM 69-189 OHMS. NO OVERSENSING OBSERVED IN S2D EGMS.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 AN ALERT WAS TRIGGERED FOR HIGH COIL IMPEDANCE THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT ALSO REPORTED THAT AN ALERT WAS TRIGGERED WHEN THEY ENTERED AN MRI ROOM BY MISTAKE, BUT THE SOUND HEARD WAS PROBABLY DUE TO "MAGNET SUSPENSION." NOISE WAS DETECTED BY TURNING THE ARM ON THE IMPLANT SIDE. A LOOSE PIN WAS IDENTIFIED BY CHEST X-RAY. THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT LEAD FRACTURE WAS SUSPECTED. DURING THE REPLACEMENT PROCEDURE AN OBVIOUS FRACTURE WAS SEEN ON FLUOROSCOPY. THE LEAD WAS CAPPED AND REPLACED AND THE DEVICE WAS REPLACED DUE TO LOW REMAINING BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657582 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTBA2D1

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 6996SQ85 LEAD