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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problem Human-Device Interface Problem (2949)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 10/15/2018
Event Type  Injury  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the axiem cable was replaced, and the issue resolved. The system then passed the system checkout and was found to be fully functional. The axiem cable was returned to the manufacturer for analysis. Analysis found that the cable appeared to be in good condition with no physical damage but a continuity test revealed an open to pin 1 of the universal serial bus (usb) cable. Analysis found that the reported event was related to a electrical issue. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a shunt axiem procedure. It was reported that intra-operatively, while switching systems, the system gave an error message on the axiem box. The site switched the axiem boxes and rebooted the system with no resolve. A manufacturer representative switched the internal cable from a different system and the issue resolved. It was then reported that after successfully registering the patient, the patient reference stopped tracking. The representative changed the port for the emitter, removed all metal from the field and turned off the berchtold high definition operating room (or) lights. The stylet was able to track continuously. The representative switched the instrument ports on the axiem box with no change. The lights were green on the axiem box no matter what port the instruments were in and the box showed a "7". It was reported that navigation was aborted and that the patient was affected. The surgeon was doing an endoscopic third ventric but the surgeon was not satisfied. There was a reported delay to the procedure of less than one hour due to this issue.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received additional information that the case was slowed down and it was harder to reach the target. The patient ended up with a shunt instead and was doing well. The procedure was completed without the use of navigation. The surgeon was not satisfied with the endoscopic third ventric because the patient had unusual anatomy and it was more difficult to find his target without working navigation.
 
Manufacturer Narrative
The tumor resection kit was returned to the manufacturer for analysis. Analysis found that the reported issue was confirmed. The tracker would not navigate. The em interface reported that coils 1 and 2 showed a navigational error. Further inspection found coils 1 and 2 were open. Analysis found that the reported event was related to an electrical issue. This issue was documented in a medtronic navigation hardware anomaly tracking database. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION S7 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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8064603
MDR Text Key126944396
Report Number1723170-2018-05629
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2014
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: 11/13/2018 Patient Sequence Number: 1
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