BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT REGULAR, PL 1.5

    MDR report key: 1915479 · Received November 5, 2010

    Report

    Report Number
    2021898-2010-00275
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    November 27, 2010
    Report Date
    October 7, 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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. NO PT INJURY WAS REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON FOUND A LEAK IN THE EXTERIOR PART OF THE DELTA CHAMBER BEFORE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT REGULAR, PL 1.5 JXG MEDTRONIC NEUROSURGERY NA C66509

    Patients

    Seq Age Sex Outcome Treatment
    1