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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 Material Integrity Problem (2978); Output Problem (3005); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2022
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 9 735843; product id: 9735820r, serial/lot #: (b)(4), udi#: (b)(4). A medtronic representative went to the site to test the equipment. Testing revealed that the camera cart orange light, scu and ethernet cord port had damage. The scu and ethernet cord ports were replaced. The navigation system then passed the system checkout and was found to be fully functional. Hardware analysis was performed. The returned systm cntrl rfb 9735820r scu vega s8 svc powered up on the test bench with a connection failure, and was not able to be tested further. The returned cable 9735843 camera ethernet kit s8 svc tested and passed on a tester. There was no apparent physical damage. (b)(4) apply to the system checkout. (b)(4) apply to the returned product id 9735820r. (b)(4) apply to the returned product id 9735843. Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that during preventative maintenance (pm) the camera was showing a fault light. There was no patient involvement. Troubleshooting was performed. The amber light on the camera was intermittently coming on and off, however the camera continuously tracked. In the ndi tool box, there was a firmware mismatch error with the scu. The network cable that plugged into the back of the camera was kinked, so the manufacturer representative (rep) bypassed the camera to the poe with a known working network cable to test, but there was no change. The rep also used the known good network cable to go from the scu to the checkpoint to see if it was a network cable issue, but there was still no change.
 
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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 Key14240697
MDR Text Key299400847
Report Number1723170-2022-00645
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00763000272760
UDI-Public00763000272760
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,Followup
Report Date 06/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
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 Manufacturer Received06/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2020
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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