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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2020
Event Type  malfunction  
Manufacturer Narrative
No products have been returned to medtronic for analysis. Codes 4114, 3221, and 4315 are applicable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information used during a sacroiliac and thoracolumbar procedure. It was reported that the site had stated that t he system had become intermittent. The site had rebooted the system and went back into navigation. However, when going back into navigate they were unable to see trajectory 1 view but were able to see all other views. The site used another navigation system to continue with the procedure. There was an unknown delay to the procedure. There was no impact to the patient.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was provided. It was reported that the procedure was delayed by 15 minutes. The system was rebooted and this resolved the issue.
 
Manufacturer Narrative
The logs were reviewed, but they did not provide any information regarding the cause of  the reported complaint. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSURGN CART 9735665 STEALTH S8 PREMIUM
Type of DeviceINSTRUMENT, STEREOTAXIC
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key10007505
MDR Text Key189358551
Report Number1723170-2020-01319
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2020
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 Manufacturer06/11/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2019
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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