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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); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  malfunction  
Event Description
Medtronic received information regarding an navigation system being used during an unknown procedure. It was reported that during surgery, the reference frame was intermittently being tracked by the camera. The site performed a system reboot and added/removed the reference frames from the procedure. The site did change the reference frames from the original navigation system to a different navigation system, as well as the spheres. Different angles were also attempted with the navigation system's arm. The 'bair hugger' and suction were turned off in the room. It was noted that the reference frame was going out every 11 seconds consistently. Once the navigation system was rebooted, the cranial frame was removed and a different navigation system frame was added. Initially, the navigation system reported it was not communicating with the imaging system although it was connected. After changing a plug in the back, the site was able to obtain images. This issue occurred intraoperatively and caused a surgical delay of less than one hour. There was no impact on patient outcome. Additional information was received. The issue was only occurring when connected to the imaging sys tem. The manufacturer representative checked the nditoolbox, and it showed all normal statuses for the system control unit (scu. ) the event logs were empty. The scu did have a status message stating "invalid command. " additional information received. It was reported this occurred during a cervical spine procedure. Additional information received. It was concluded that the frames was not the issue and the issue was a cord that fed into the camera. That was replaced and so far no more issues have occurred.
 
Manufacturer Narrative
Device evaluated by mfr: wo00872770- a medtronic representative went to the site to test the equipment. Testing revealed that no failure found. The system then passed the system checkout and was found to be fully functional. (b)(4). Device evaluated by mfr: wo00873944- a medtronic representative went to the site to test the equipment. Testing revealed that the bulkhead/cable was replaced. The system then passed the system checkout and was found to be fully functional. (b)(4). Analysis found on cable/bulkhead- analysis determined there was no failure found. (b)(4). Continuation of concomitant medical products: other relevant device(s) are: product id: 9735843, serial/lot #: unknown. 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 Key13011500
MDR Text Key289900916
Report Number1723170-2021-02893
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2021
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? No
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2020
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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