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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733858
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 03/24/2020
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Report source foreign country: (b)(6). The manufacture representative went to the site to test the navigation system. The reported issue was not confirmed and no parts were replaced. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported outside of a procedure that upon inspection it was found that both monitors were flickering after several startup and application changes/restarts. No patient was present at the time of the event. Additional information received stating that the system is operating perfectly.
 
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Brand NameSTEALTHSTATION® S7
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 Key9943826
MDR Text Key187080251
Report Number1723170-2020-01191
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K050438
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
Report Date 04/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733858
Device Catalogue Number9733858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2014
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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