BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5

    MDR report key: 2193601 · Received July 14, 2011

    Report

    Report Number
    2021898-2011-00148
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 17, 2011
    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 INITIAL REPORT STATED THE PRODUCT DID NOT HAVE PT CONTACT. HOWEVER, THE VALVE WAS COVERED IN PROTEINACEOUS DEBRIS. THIS SUGGESTS THE DEVICE DID COME INTO CONTACT WITH THE PT. THE VALVE WAS PATENT. IT ALSO PASSED SIPHON AND REFLUX TESTING. HOWEVER, THE VALVE DID NOT PASS LEAK TESTING DUE TO A TEAR IN THE BOTTOM OF THE DELTA CHAMBER. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THE VALVE MET ALL REQUIREMENTS FOR PRESSURE-FLOW AND PRE-IMPLANTATION TESTING. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. NO IMPACT TO THE PT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DOCTOR ALLEGEDLY FOUND PRODUCT LEAKAGE BEFORE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D01064

    Patients

    Seq Age Sex Outcome Treatment
    1