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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number I7
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2016
Event Type  malfunction  
Manufacturer Narrative
On 11/16/2016 software engineer analysis of patient logs revealed an error occurred that caused the unexpected exit. Software investigation was completed. This issue was documented in a medtronic software anomaly tracking database. Return requested. Replacement equip rack i7 transceiver, nav interface i7 transceiver, i/o hub i7, usb optical extender kit and i7 nav interface cable clamp were all shipped to site 11/21/2016. No parts have been received by manufacturer for analysis. On 11/29/2016 a medtronic representative performed a navigation system check-out, software and instruments areas passed. Hardware test failed. Navigation system continued to lock and become unresponsive. Replaced transceivers with upgraded transceivers and issue was resolved. System performed as intended.
 
Event Description
A medtronic representative reported that, while in a cranial procedure, the surgeon alleged their navigation system became unresponsive. A medtronic representative recommended re-starting the navigation system to restore normal function. The site re-started the rack, but left the navigation interface unit (niu) on and this resolved the issue. The unresponsive screen occurred during navigation when the surgeon requested to switch to a microscope probe and when he tried to navigate with the probe the software was unresponsive and the touch screen was not responding. The site then re-started the rack computer and logged back into the cranial optical software and it worked and tracked normally. The niu was left on during this procedure. The surgeon opted to continue and completed the procedure with the use of the navigation system. Delay in therapy was 5 - 10 minutes. There was no impact on patient outcome reported.
 
Manufacturer Narrative
The i/o hub was returned to the manufacturer for analysis. The i/o hub was tested on bench tester and was found to be working as expected. I/o hub was updated with new rev. Due to compatibility issues when updating rack and niu transceivers. The device was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. The usb optical extender kit and i7 nav interface cable clamp were returned unused and unrelated to the cause of the reported event. The equip rack transceiver and nav interface transceiver have been received and are currently under analysis.
 
Manufacturer Narrative
The suspect computer was returned to the manufacturer for analysis. The computer was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. The equipment rack transceiver was returned to the manufacturer for analysis. Testing found that the reported issue could occur, but the freezing was linked to a software issue. The nav interface transceiver was returned to the manufacturer for analysis. When paired with the equipment rack transceiver, the reported issue could be replicated and could be linked to the software investigation conducted by medtronic representative.
 
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Brand NameSTEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
826 coal creek circle
louisville, CO 80027-9710
7208902082
MDR Report Key6171911
MDR Text Key62319616
Report Number1723170-2016-05684
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 02/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberI7
Device Catalogue Number9734060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2010
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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