BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7´

    MDR report key: 8741005 · Received June 27, 2019

    Report

    Report Number
    1723170-2019-03843
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    April 23, 2018
    Report Date
    June 27, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A HARDWARE ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE. ANALYSIS FOUND THAT CASEPART-(B)(4) HAD PIN 11D IS BENT ON THE ODU-MAC CONNECTOR OF THE RETURNED CABLE. A CONTINUITY TEST REVEALED AN OPEN FROM PIN 3 OF THE LARGE LEMO CONNECTOR TO PIN 3B OF THE ODU-MAC CONNECTOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT PRESENT. IT WAS REPORTED THAT THERE WAS NO RED INJECTED IN THE OCULARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534101 STEALTHSTATION® S7´ INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733857

    Patients

    Seq Age Sex Outcome Treatment
    1