BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 14111305 · Received April 14, 2022

    Report

    Report Number
    3001587388-2022-22187
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 28, 2022
    Report Date
    April 14, 2022
    Manufacturer
    SOPHYSA
    Product Code
    GWM
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE IMPLANTED FOR INTRACRANIAL PRESSURE MONITORING. HEALTH PROFESSIONAL REPORTED AN IMPORTANT SPONTANEOUS VARIATION IN ICP VALUES DISPLAYED ON THE MONITORING SCREEN WITHOUT ANY STIMULATION. THE VALUES INCREASED FROM NORMAL ICP VALUE (>20MMHG) TO OVER 100MMHG. THE REPORT ALSO STATES THAT THE PATIENT'S CLINICAL STATE DOES NOT CORRESPOND TO ICP VALUES. A SCAN DID NOT FIND ARGUMENTS FOR IC HYPERTENSION. THE INCIDENT RESULTED IN PROLONGED STAY IN HOSPITAL (REANIMATION). THE DEVICE WAS EXPLANTED AND REPLACED. THIS INCIDENT IS DUPLICATED FOR 5 OTHER DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107893 SOPHYSA PSO-PT GWM SOPHYSA PSO-PT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O