BEUDAMED
    FDA Adverse Event Death Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 6049000 · Received October 21, 2016

    Report

    Report Number
    3004936110-2016-00055
    Event Type
    Death
    Date Received
    October 21, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 30, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC. - CARDIOMEMS
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS IN RELATION TO A CLINICAL STUDY PATIENT. IT WAS REPORTED PATIENT UNDERWENT A SENSOR IMPLANT PROCEDURE ON (B)(6) 2016. THE FOLLOWING DAY, THE PATIENT FELL DUE TO WEAKNESS. THE FALL RESULTED IN A FRACTURE BETWEEN C7 AND T1. IN TURN, THE PATIENT WAS PLACED IN A NECK BRACE. ON (B)(6) 2016, THE PATIENT'S BREATHING BEGAN TO DETERIORATE. NEXT, THE PATIENT BEGAN TO EXPERIENCE CHRONIC SYSTOLIC CONGESTIVE HEART FAILURE AND FLASH PULMONARY EDEMA. AS A RESULT, THE PATIENT WAS SENT TO HOSPICE CARE AND PASSED AWAY ON (B)(6) 2016. IT WAS NOTED THE REPORTED EVENT WAS NOT DEVICE OR PRODUCT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698188 HF SENSOR DELIVERY SYSTEM IMPLANTABLE HF SENSOR AND DELIVERY SYSTEM MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM2000 5360330

    Patients

    Seq Age Sex Outcome Treatment
    1 Death