BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT, SMALL, PERFORMANCE LEVEL 1

    MDR report key: 2182223 · Received July 12, 2011

    Report

    Report Number
    2021898-2011-00147
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERITONEAL CATHETER WAS TORN INTO TWO PIECES. THE TORN ENDS DID NOT HAVE STRAIGHT EDGES. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THE TWO SEGMENTS WERE PATENT AND PASSED LEAK TESTING WHEN TESTED INDIVIDUALLY. THE CATHETER ALSO MET ALL SPECIFICATIONS FOR TENSILE STRENGTH AND ULTIMATE ELONGATION. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT "LOW TEAR STRENGTH IS A CHARACTERISTIC OF MOST UNREINFORCED SILICONE ELASTOMER MATERIALS. CARE MUST BE TAKEN WITH THE HANDLING AND PLACEMENT OF THE SILICONE ELASTOMER CATHETER TUBING TO AVOID CUTS, NICKS OR TEARS". A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL COMPONENTS OF OUR SHUNT SYSTEMS ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING AN IMPLANTATION SURGERY, THE DOCTOR ALLEGEDLY FOUND THE PERITONEAL CATHETER BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT, SMALL, PERFORMANCE LEVEL 1 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C27452

    Patients

    Seq Age Sex Outcome Treatment
    1