BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 PREMIUM SYSTEM

    MDR report key: 8957326 · Received September 3, 2019

    Report

    Report Number
    1723170-2019-04736
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 9, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ACC 960-537 ARM ARTICULATING. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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 SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE ARTICULATING ARM WOULD NOT TIGHTEN. THIS WAS DISCOVERED OUTSIDE OF A CASE WITH NO PATIENT PRESENT DURING SET-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751190 STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1