BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 8649241 · Received May 29, 2019

    Report

    Report Number
    3004936110-2019-00267
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 10, 2019
    Report Date
    August 26, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC. - CARDIOMEMS
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE DHR WAS PERFORMED AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE. THE SIGNAL ACQUISITION ISSUE WAS CAUSED BY AN ANGLE OF THE SENSOR IN RELATION TO THE PATIENT ELECTRONIC UNIT WHERE A SIGNAL COULD NOT BE MADE.

    Description of Event or Problem · 0

    THE SENSOR MIGRATED AND NO READINGS HAVE BEEN POSSIBLE WITH THE PATIENT ELECTRONIC UNIT(PEU) OR HOSPITAL ELECTRONIC UNIT (HEU). X-RAY MEASUREMENT CONFIRMS DISTANT SENSOR TO SPIN 15 CM. ANOTHER SENSOR WAS IMPLANTED.

    Description of Event or Problem · 1

    THE SENSOR MIGRATED AND NO READINGS HAVE BEEN POSSIBLE WITH THE PATIENT ELECTRONIC UNIT OR HOSPITAL ELECTRONIC UNIT. X-RAY MEASUREMENT CONFIRMS DISTANT SENSOR TO SPIN 15 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445426 HF SENSOR DELIVERY SYSTEM IMPLANTABLE HF SENSOR AND DELIVERY SYSTEM MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM2000 6736296 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other