BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-SNAP SHUNT VENTRICULAR CATHETER KIT

    MDR report key: 10514924 · Received September 10, 2020

    Report

    Report Number
    2021898-2020-00230
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Report Date
    September 10, 2020
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K911382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS ATTEMPTED TO BE USED; HOWEVER, IT WAS NOT WORKING DURING THE CASE SO IT WAS DEEMED DEFECTIVE. THERE WAS NO PATIENT IMPACT. (B)(6) 2020 NNI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977380 CSF-SNAP SHUNT VENTRICULAR CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 24094 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1