BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS SPV VALVE ADJUSTABLE 10-140

    MDR report key: 3952184 · Received May 12, 2014

    Report

    Report Number
    3001587388-2014-00142
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    March 22, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO THE MANUFACTURER ON (B)(4) 2014; RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT. THE DEVICE HAS NOT BEEN RETURNED YET.

    Description of Event or Problem · 1

    SPV-140 WAS IMPLANTED ON (B)(6) 2014. THE SURGEON FIXED THE PRESSURE SETTING TO 80MMH2O BUT THE PATIENT SUFFERED FROM HYPERDRAINAGE. IT WAS NOT POSSIBLE TO ADJUST THE VALVE PRESSURE, VALVE BLOCKED. THEREFORE THE SURGEON REPLACED IT WITH ANOTHER SPV-140 AT THE PRESSURE SETTING OF 110 THEN 140 MMH2O, ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283900 POLARIS SPV VALVE ADJUSTABLE 10-140 VALVE ADJUSTABLE POLARIS JXG SOPHYSA VALVE POLARIS A0307

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention