BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT, SMALL, PERFORMANCE LEVEL 1.5

    MDR report key: 1963789 · Received December 22, 2010

    Report

    Report Number
    2021898-2010-00360
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    August 19, 2010
    Report Date
    November 22, 2010
    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

    (B)(4). THE PERITONEAL CATHETER WAS TORN IN TWO PIECES. IT IS UNKNOWN HOW THE DAMAGE OCCURRED. THE CATHETER MET ALL SPECIFICATIONS FOR TENSILE STRENGTH AND ULTIMATE ELONGATION TESTING. A REVIEW OF MANUFACTURING RECORDS SHOWED NO ANOMALIES. 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." NO IMPACT TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERITONEAL CATHETER BROKE DURING SURGERY, SO ANOTHER PRODUCT WAS USED AND THE OPERATION WAS FINISHED SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT, SMALL, PERFORMANCE LEVEL 1.5 JXG MEDTRONIC NEUROSURGERY NA C60403

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK