BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD XT

    MDR report key: 3990734 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14397
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 25, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE PATIENT WAS A PARTICIPANT IN THE (B)(6) STUDY. THE IMPLANTABLE CA RDIOVERTER DEFIBRILLATOR (ICD) SYSTEM POCKET WAS SCHEDULED FOR A REVISION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472212 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBX1QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R 5076-45 LEAD, 429888 LEAD, 6935M55 LEAD