BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT DR

    MDR report key: 3992168 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14892
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    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. CONCOMITANT MEDICAL PRODUCTS: 5554-45 LEA,D IMPLANTED:(B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT SIX DAYS POST IMPLANT THE PATIENT DEVELOPED A HEMATOMA IN THE POCKET. IT WAS NOTED THAT THE PATIENT HAS FACTOR XI DEFICIENCY, A PLATELET DISORDER, AND TOOK ASA (ACETYLSALICYLIC ACID). THE POCKET WAS CLEANED AND EVACUATED. THE DEVICE REMAINS 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
    470514 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R 6944-58 LEAD