BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 7338589 · Received March 14, 2018

    Report

    Report Number
    3004936110-2018-00081
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    February 15, 2018
    Report Date
    February 7, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC. - CARDIOMEMS
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE SENSOR RECALIBRATION BY RIGHT HEART CATHETERIZATION ON (B)(6) 2019. 38 MMHG WAS ADDED TO THE CM MEAN. ACCURATE READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S READINGS ARE CLINICALLY CONSISTENT WITH SIGNS OF DAMPENED WAVEFORMS. IT HAS BEEN RECOMMENDED THAT THE CLINIC EVALUATE FOR POSSIBLE CAUSE OF REDUCED BLOOD FLOW TO THE SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183316 HF SENSOR DELIVERY SYSTEM IMPLANTABLE HF SENSOR AND DELIVERY SYSTEM MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM2000 5181165

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other