BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE

    MDR report key: 2870047 · Received December 10, 2012

    Report

    Report Number
    2648988-2012-00055
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K760501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INVOLVING A PUDENZ (16MM, BURR HOLD, LOW PRESSURE) VALVE WHICH WAS DESCRIBED AS FOLLOWS; "DURING THE PATENCY TEST, THE NEUROSURGEON PUMPED IT BUT, PHYSIOLOGICAL SALINE DID NOT ENTER THE VALVE WELL. HE USED ANOTHER STOCK ITEM. NO HARM TO THE PATIENT, IT DELAYED OPERATION FOR AROUND 15 MINUTES." THE UNIT WAS IN CONTACT WITH A PATIENT HOWEVER, IT IS UNKNOWN IF THE PATIENT WAS ANESTHETIZED DURING THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE NA JXG INTEGRA NEUROSCIENCES PR 1120413R

    Patients

    Seq Age Sex Outcome Treatment
    1