BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 4972144 · Received August 5, 2015

    Report

    Report Number
    3004209178-2015-15298
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    February 24, 2015
    Report Date
    June 8, 2015
    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
    LA, 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEART FAILURE SYMPTOMS INCLUDING SHORTNESS OF BREATH. HIGH THRESHOLDS ON THE LEFT VENTRICULAR (LV) LEAD WERE REPORTED. IT WAS FURTHER REPORTED BY THE PATIENT THAT THE THE CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) "DIDN'T LAST AS LONG AS IT WAS SUPPOSED TO." COMMUNICATION WITH CLINIC INDICATED THAT THE LEFT VENTRICULAR (LV) LEAD HIGH THRESHOLDS PREVIOUSLY REPORTED WERE CHRONIC DUE TO PATIENT ANATOMY AND " MAY HAVE LED TO EARLY BATTERY DRAIN" ON THE CRT-D. THE DEVICE AND THE LV LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513108 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R 694765 LEAD, 407645 LEAD, 419678 LEAD