BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT, REGULAR, PL 1.5

    MDR report key: 3172178 · Received June 5, 2013

    Report

    Report Number
    2021898-2013-00196
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. CRYSTALLINE DEBRIS WAS OBSERVED IN THE INTERIOR OF THE VALVE. NO PROTEINACEOUS DEBRIS WAS OBSERVED. THE VALVE MET REQUIREMENTS FOR THE SIPHON, REFLUX, LEAKAGE, AND PREIMPLANTATION TESTS. IT ALSO MET ALL THE REQUIREMENTS FOR THE PRESSURE-FLOW TESTS. THEREFORE, THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LAB PERSONNEL. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. A 23.6 CM OF THE VENTRICULAR CATHETER WAS RETURNED. THE CATHETER WAS PATENT. IT DID NOT MEET REQUIREMENTS FOR THE LEAKAGE TEST DUE TO A TEAR. THE CATHETER MET REQUIREMENTS FOR THE TENSILE STRENGTH AND ULTIMATE ELONGATION TESTS. IT IS UNK HOW OR WHEN THE DAMAGE OCCURRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE IMPLANTATION SURGERY, THE PHYSICIAN FOUND THAT THE CHAMBER OF THE VALVE LEAKED. THE PHYSICIAN REPORTED THAT HE SAW A TEAR AND DECIDED TO NOT USE THE VALVE. HE USED A NEW SHUNT KIT TO COMPLETE THE OPERATION. IT WAS ALSO REPORTED THAT THE PT IS OVERALL DOING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249156 DELTA SHUNT KIT, REGULAR, PL 1.5 JXG MEDTRONIC NEUROSURGERY D17970

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR