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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 Computer Software Problem (1112)
Patient Problem Brain Injury (2219)
Event Date 05/29/2019
Event Type  Injury  
Manufacturer Narrative
Patient demographic information was refused by the site. No parts have been received by the manufacturer for evaluation. Medwatch mw5087195. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used in an electrode and probe placement procedure (deep brain stimulation (dbs) procedure). It was reported that during stimulation of the microelectrode the patient was having response on the right side of his body when there should have been responses on the left side of his body. Discussions were held between the neurologist and the neurosurgeon. During discussions, it was noted that on the navigation system the system showed they were in navigation mode for the right side of the body and not the left. But when they switched back to the planning screen on the navigation system, the system switched the screen to the left side of the body. They were able to replicate this issue multiple times, and there were multiple attempts to troubleshoot without success. The procedure was aborted due to safety concerns to the patient. The neurosurgeon ordered a ct scan stat for the patient and then when to the recovery room. The ct scan noted blood and free air in the patient's third ventricle. The alleged inaccuracy was noted with a 5mm difference between plan 1 and plan 2 of navigation. There was a delay to the procedure of less than an hour.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The imaging system passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Software analysis through design analysis revealed that the software was functioning as designed. The behavior described is the intended behavior of the software. 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 Key8732063
MDR Text Key149115330
Report Number1723170-2019-03811
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
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 08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2014
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: 06/25/2019 Patient Sequence Number: 1
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