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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7 STAFF ASSEMBLED INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC S7 STAFF ASSEMBLED INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problems Human-Device Interface Problem (2949); Audible Prompt/Feedback Problem (4020)
Patient Problem No Patient Involvement (2645)
Event Date 01/30/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used outside of a procedure. It was reported that there the monitor was beeping when plugged in and the camera lights were flashing. The site did trouble shooting at the time of the event and there was no position sensor unit (psu) listed it was noted that it was likely disconnected. The sensor control unit (scu) would not produce logs they attempted upgrading setup utility but it was unable to pass first step. There was no patient involved.
 
Manufacturer Narrative
The sensor control unit was sent out for vendor analysis. The issue was confirmed and isolated to the internal mainboard which was replaced. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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Brand NameS7 STAFF ASSEMBLED
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 Key9659725
MDR Text Key177648656
Report Number1723170-2020-00330
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Device Lot NumberT303969
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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