BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS SPV VALVE ADJUSTABLE ANTECHAMBER50-300

    MDR report key: 3952163 · Received May 12, 2014

    Report

    Report Number
    3001587388-2014-00136
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    February 14, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO THE MANUFACTURER ON 03/28/2014; RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    SPVA-300 WAS IMPLANTED IN (B)(6) 2010. AS THE PATIENT SUFFERED FROM HEADACHE. THE SURGEON CHECKED THE SYSTEM UNDER X-RAY TO FIND THE RESERVOIR DETACHED FROM THE VALVE. HE EXTRACTED THE SYSTEM AND IMPLANTED SPVA. THEN, THE CONDITION OF THE PATIENT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284337 POLARIS SPV VALVE ADJUSTABLE ANTECHAMBER50-300 VALVE ADJUSTABLE POLARIS WITH RESERVOIR JXG SOPHYSA VALVE POLARIS X0080

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention