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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2017
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site.No parts were replaced.No parts have been received by manufacturer for evaluation.Part not returned for evaluation.
 
Event Description
A medtronic representative reported that during a spinal fusion procedure, both monitors of the navigation system went black and displayed a no signal on the screen.Representative tried moving the mouse but had no change.Hard shutdown of the system was performed and when the system was powered back up the issue was resolved and the system was functioning normally.The procedure was completed with the use of navigation.There was no delay to the procedure as the issue occurred prior to start of procedure.No impact on patient outcome.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The logs for the navigation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.
 
Manufacturer Narrative
The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.
 
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Brand Name
STEALTHSTATION S7 SYSTEM
Type of Device
NEUROLOGICAL 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
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key6848341
MDR Text Key85127979
Report Number1723170-2017-03648
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 12/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberS7
Device Catalogue Number9733856
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/10/2017
Initial Date FDA Received09/07/2017
Supplement Dates Manufacturer Received08/11/2017
11/14/2017
Supplement Dates FDA Received11/06/2017
12/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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