BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC LUMBOPERITONEAL SHUNT KIT

    MDR report key: 6915794 · Received October 5, 2017

    Report

    Report Number
    2021898-2017-00501
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 4, 2017
    Report Date
    October 4, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169010796
    PMA / PMN Number
    K091312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE LUMBAR CATHETER WAS RETURNED. THE CATHETER WAS PATENT. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING. THE CATHETER WAS OBSERVED TO BE SHEARED OFF APPROXIMATELY 24CM FROM THE PROXIMAL END. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THE CATHETER MET THE REQUIREMENTS FOR THE TENSILE STRENGTH AND ELONGATION TESTS. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTIONS THAT LOW TEAR STRENGTH IS A CHARACTERISTIC OF MOST UNREINFORCED SILICONE ELASTOMER MATERIALS, AND THAT CARE MUST BE TAKEN WITH THE HANDLING AND PLACEMENT OF THE SILICONE ELASTOMER CATHETER TUBING TO AVOID CUTS, NICKS, OR TEARS. IT ALSO CAUTIONS THAT TO AVOID POSSIBLE TRANSECTION OF THE CATHETER DURING CATHETER PLACEMENT, THE CATHETER SHOULD NEVER BE WITHDRAWN THROUGH THE TUOHY NEEDLE. IF THE CATHETER NEEDS TO BE WITHDRAWN, THE TUOHY NEEDLE, GUIDEWIRE, AND THE CATHETER MUST BE REMOVED SIMULTANEOUSLY. THERE WAS PROTEINACEOUS DEBRIS OBSERVED WITHIN THE INTERIOR AND EXTERIOR OF THE CATHETER. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON DID THE PRE-SURGERY SHUNT TESTING, THE LUMBAR CATHETER WAS LEAKING. THE CATHETER WAS REPLACED AND THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697796 STRATA NSC LUMBOPERITONEAL SHUNT KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 44420 E26768 00643169010796

    Patients

    Seq Age Sex Outcome Treatment
    1