BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT REGULAR, PL 1.5

    MDR report key: 1994309 · Received January 14, 2011

    Report

    Report Number
    2021898-2011-00015
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    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

    (B)(4). THE PRODUCT PACKAGING WAS RETURNED CONTAINING THE CATHETERS, THE STYLET AND THE RIGHT ANGLE CLIP. THE VALVE WAS NOT RETURNED. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE AND THE COMPLAINT COULD NOT BE VERIFIED. MEDTRONIC NEUROSURGERY HAS RECEIVED NO OTHER COMPLAINTS FOR THIS LOT AND A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. NO IMPACT TO THE PT WAS REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    DURING THE SURGERY, WHEN THE DR OPENED THE PACKAGE, HE FOUND A LEAK IN THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT REGULAR, PL 1.5 JXG MEDTRONIC NEUROSURGERY NA C40559

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK