BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2953300 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01928
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    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 PRODUCT: 4195 NON-DEFIB LEAD (B)(6) 2011; 4592 NON-DEFIB LEAD (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY WERE DIAGNOSED WITH "DEEP VEIN TROMBOSIS (DVT) THAT PROTRUDES IN THE AXIAL VEIN". PATIENT ALSO REPORTED THAT IT IS A "KNOWN FACT" THAT IMPLANTED HEART DEVICES MAY RESULT IN DVT. THE PATIENT STATES THEY WERE NOT INFORMED OF THIS RISK PRIOR TO IMPLANT BY PHYSICIAN OR MEDTRONIC AND INDICATED DVT IS A "LIFE THREATENING EVENT". THE PATIENT IS WORKING WITH PHYSICIAN TO DETERMINE THE CAUSE OF DVT AND QUESTIONED WHAT MEDTRONIC IS DOING TO LOWER RISK MOVING FORWARD. THE DEVICE AND LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56539 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening 6947 DEFIB LEAD