BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 4831236 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-10799
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE AND HIGH IMPEDANCE DUE TO A LOOSE SETSCREW ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE LEAD WAS REMOVED, REINSERTED INTO THE HEADER, AND THE TIGHTENED. THE RV LEAD AND ICD REMAIN 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
    379538 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 694765 LEAD, 419488 LEAD, 5076-52 LEAD