BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA VALVE, REGULAR, PL 1.5

    MDR report key: 2926450 · Received January 15, 2013

    Report

    Report Number
    2021898-2013-00014
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. IT MET REQUIREMENTS FOR THE SIPHON AND REFLUX TESTINGS. IT, HOWEVER, DID NOT MEET REQUIREMENTS FOR THE PREIMPLANTATION AND LEAKAGE TESTINGS. IT ALSO DID NOT MEET ALL OF THE REQUIREMENTS FOR THE PRESSURE-FLOW TESTINGS. A CRACK IN THE PLASTIC CASING OF THE DELTA CHAMBER WAS OBSERVED. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE IMPLANTATION SURGERY THE DOCTOR FOUND THE VALVE TO BE LEAKING. THEY THEN USED A NEW VALVE TO FINISH THE SURGERY. IT WAS ALSO REPORTED THAT THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22217 DELTA VALVE, REGULAR, PL 1.5 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D29932

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR