BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 3860145 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10628
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT MEDICAL PRODUCTS: 694765, LEAD, IMPLANTED: (B)(6) 2009; 5076-52, LEAD, IMPLANTED: (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, AN ALERT WAS TRIGGERED FOR HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD FOR BOTH THE RV COIL AND SVC COIL. THE ALERTS WERE TURNED OFF. THE FOLLOWING DAY ANOTHER ALERT WAS TRIGGERED. A CHEST X-RAY SHOWED THAT THE RV COIL CONNECTOR WAS NOT FULLY INSERTED. ANOTHER SURGERY WAS TO BE PLANNED TO RECONNECT THE LEAD. THE DEVICE AND LEAD 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
    337051 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R 4194-88 LEAD