BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 9699301 · Received February 12, 2020

    Report

    Report Number
    3004936110-2020-00043
    Event Type
    Injury
    Date Received
    February 12, 2020
    Report Date
    February 12, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINED 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE FOLLOWING ARTICLE: RALIA S, SHAH Z, SAUER A, GUPTA K. LATE MIGRATION OF A CARDIOMEMS WIRELESS PULMONARY ARTERY HEMODYNAMIC MONITORING SENSOR. CIRC HEAR FAIL. 2017;10 (4): E003948. HTTPS://DOI.ORG/10.1161/CIRCHEARTFAILURE.117.003948. FOUR MONTHS FOLLOWING A SUCCESSFUL CMEMS SENSOR IMPLANT PROCEDURE, THE SIGNAL WAS LOST AND NO SENSOR READINGS COULD BE OBTAINED. A CHEST X-RAY WAS DONE TO CONFIRM THE SENSOR POSITION AND IT SHOWED THE SENSOR HAD MIGRATED TO THE RIGHT LUNG. ONCE THE SENSOR POSITION WAS IDENTIFIED, READINGS WERE ABLE TO BE OBTAINED BY PLACING THE WAND OVER THE NEW LOCATION. THERE WERE NO ADVERSE OUTCOMES THAT OCCURRED WITH THE PATIENT AND THE SENSOR CONTINUED TO PERFORM WELL IN THE MIGRATED LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165997 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 5102593 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other