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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Environmental Compatibility Problem (2929)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. No parts have been received by the manufacturer for evaluation. 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 while setting up for a procedure. It was reported that the camera cart of the navigation system had powered down after half an hour of being powered on. It was noted that the main cart remained powered on. There was no patient present when this issue was identified.
 
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Brand NameSTEALTHSTATION S8 SYSTEM
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key11049550
MDR Text Key225546334
Report Number1723170-2020-03364
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
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 Manufacturer02/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2020
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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