BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2955388 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01013
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 30, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    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; 6947 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 THROMBOSIS (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
    59721 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-53

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening (B)(4) BI-V DEFIBRILLATOR