BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD XT

    MDR report key: 4834047 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-11087
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 26, 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
    OH, 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 ABOUT TWO WEEKS AFTER THE IMPLANT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A DEEP VEIN THROMBOSIS (DVT) OF THE LEFT UPPER EXTREMITY DUE TO THE DEVICE IMPLANT PROCEDURE, AND THE PATIENT WAS ALSO EXPERIENCING DIAPHRAGMATIC STIMULATION DUE TO THE LEFT VENTRICULAR LEAD. MEDICATION WAS STARTED TO RESOLVE THE DVT AND THE LEAD WAS REPROGRAMMED. THE DEVICE AND LEAD REMAIN IN USE. THE PATIENT WAS A PARTICIPANT IN THE ADAPT RESPONSE CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380335 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention 5076-52 LEAD, 4298-88 LEAD, 6935M-62 LEAD