BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE

    MDR report key: 2070201 · Received April 7, 2011

    Report

    Report Number
    3001587388-2011-00062
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    February 24, 2011
    Report Date
    April 7, 2011
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO THE MANUFACTURER ON (B)(4) 2011. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    AN SPVB WAS IMPLANTED IN (B)(6), 2010. IT HAD BEEN WORKING WELL BUT THE PT STARTED TO SUFFER FROM HYPODRAINAGE. THE SURGEON THEN CHANGED THE VALVE SETTING TO 70 BUT THE PT'S CONDITIONS DID NOT IMPROVE. THEREFORE, HE REPLACED THE VALVE. HE WOULD LIKE TO KNOW THE REASON OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE VALVE HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS VALVE W0284

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR