BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 13227447 · Received January 11, 2022

    Report

    Report Number
    1723170-2022-00038
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 21, 2021
    Report Date
    January 11, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821, SERIAL/LOT #: P9-03813, UBD: , UDI#: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA OF THE NAVIGATION SYSTEM COULD NOT DETECT POINTERS AND REFERENCE FRAMES. TROUBLESHOOTING FOUND THAT THE CAMERA HAD AN ILLUMINATOR HARDWARE FAULT AND THE CAMERA WAS SUBSEQUENTLY REPLACED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624760 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown