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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 Tissue Damage (2104)
Event Date 03/31/2020
Event Type  Injury  
Manufacturer Narrative
No parts have been returned for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure. It was reported that during spine surgeries the navigation system loses accuracy and leads to inaccurate screw placement.
 
Manufacturer Narrative
Additional information indicated this was the first of three related events. Refer to mfg. Report# 1723170-2020-01267 and mfg. Report# 1723170-2020-01261 for the other events. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative indicated the issue resulted in a procedure delay of 30 minutes.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. It was reported that the issue could not be confirmed or replicated, no components were replaced. The system then passed the system checkout and was found to be fully functional. After further review, it was determined the other possible cases experiencing inaccuracy with respect to the same site include mfr report# 3004785967-2019-00350 and mfr report# 3004785967-2019-00360. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative indicated the number of patients affected was unknown. The associated procedure delay due to the reported issue was significant in some cases, but the length was unknown.
 
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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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key9917866
MDR Text Key186211716
Report Number1723170-2020-01145
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2020
Is this an Adverse Event Report? Yes
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/02/2020 Patient Sequence Number: 1
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