BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 3993449 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14621
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT WHEN THE LEADS WERE HOOKED UP TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPEDANCE MEASUREMENTS WERE NOT ABLE TO BE OBTAINED AND THERE WAS NOISE ON THE ELECTROGRAMS. THE LEADS WERE REMOVED AND REINSERTED, HOWEVER, THE ISSUE WAS NOT RESOLVED. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471295 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR