BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-UNITIZED SHUNT KIT, CONTOURED SMALL, LOW, 8CM

    MDR report key: 1834443 · Received September 10, 2010

    Report

    Report Number
    2021898-2010-00216
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K841442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VALVE WAS NOT PATENT DUE TO TWO LARGE TEARS ON THE RESERVOIR DOME ABOUT THE VALVE MEMBRANE. THE DISTAL CATHETER WAS CUT APPROXIMATELY 1 INCH FROM THE VALVE. THE EDGES OF THE CUT WERE UNEVEN. THERE WAS A SMALL TEAR ON THE RIGHT ANGLE VENTRICULAR CATHETER NEAR THE INLET CONNECTOR. THE DAMAGED CONDITION OF THE VALVE PRECLUDED FURTHER TESTING. IT IS UNK HOW OR WHEN THESE DAMAGES OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT IMPROPER USE OF INSTRUMENTS IN THE HANDLING OR IMPLANTATION OF SHUNT PRODUCTS MAY RESULT IN THE CUTTING, SLITTING OR CRUSHING OF COMPONENTS. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE SHUNT WAS IMPLANTED, THE DOCTOR PULLED ON THE DISTAL CATHETER TO MOVE THE VALVE DISTALLY AND THE CATHETER DETACHED FROM VALVE. HE WAS PULLING HARD AND HAD TENSION ON VALVE. IT LOOKED LIKE MUSCLE OR TISSUE WAS PROHIBITING THE VALVE FROM ADVANCING. THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-UNITIZED SHUNT KIT, CONTOURED SMALL, LOW, 8CM JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK