BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 NAVIGATION

    MDR report key: 10578279 · Received September 24, 2020

    Report

    Report Number
    1723170-2020-02513
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 23, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PN: 9733597, LN: 160921. A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE SYSTEM AND THE AXIEM POWER CABLE WAS REPLACED. THE CABLE WAS RETURNED FOR ANALYSIS. ANALYSIS DETERMINED THAT THERE WAS AN ELECTRICAL FAILURE. THE RETURNED CABLE HAD NO APPARENT PHYSICAL DAMAGE BUT A CONTINUITY TEST REVEALED A SHORT FROM THE SHIELD TO PIN 4 OF THE USB CABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    (B)(4) (REP): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE POWER CABLE IS DAMAGED ON THE AXIEM NOT ALLOWING THE SYSTEM TO GET POWER. THIS HAPPENED PRIOR TO THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048801 STEALTHSTATION S7 NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1