BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA XT DR

    MDR report key: 5046741 · Received September 1, 2015

    Report

    Report Number
    3004209178-2015-17085
    Event Type
    Death
    Date Received
    September 1, 2015
    Date of Event
    October 24, 2014
    Report Date
    August 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT IS DECEASED AND THAT THE DEVICE SYSTEM CONTRIBUTED TO THE DEATH. IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED A HEMATOMA AFTER IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY 3 WEEKS AFTER IMPLANT OF THE DEVICE SYSTEM. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578589 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death