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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735665
Device Problems Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2021
Event Type  malfunction  
Event Description
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that the local representative (cc) called in to troubleshoot connecting an imaging system to the navigation system. The cc was unable to setup the network configuration to get the navigation system connected to the imaging system. The following steps were followed when attempting to refresh the network data on the navigation system: get current configuration; "firewall model 1430" waslisted; then "retrieving firewall network configuration, please wait"; finally, "retrieving the firewall status, timed out. " the following steps were followed when attempting to update the ip address information in the system: network configuration was set, updated the status, and then verification of the network configuration failed. Multiple reboots, including a full reboot with the power cord unplugged, did not resolve the issue. It was later reported that after troubleshooting, the router was pinged and was responding. Connection with internal devices was then working. There was no patient involvement.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that hardware was replaced. The system then passed the system checkout and was found to be fully functional. (b)(4). Analysis found on net sec app-wired-confd- analysis determined the checkpoint was tested and found to have wan port configuration missing. Was able to restore the configuration by setting the ip address to dhcp and then re-configuring to static ip. (b)(4). Other relevant device(s) are: product id: 9 735994, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION¿ S8 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13003327
MDR Text Key283945515
Report Number1723170-2021-02885
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2021
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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