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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 Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
Patient gender, date of birth, ethnicity and race were unavailable from the site. No parts have been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation device being used for a spinal fusion procedure. It was reported that the site was preparing for navigation. The imaging system's 3d scan transmitted to system then the software showed the message "exiting" and froze. They restarted the system and the issue reoccurred. On site, there was a reinstall of the spine software and deletion of the last patient,which may have produced the error. This did not resolve the issue. An error message indicating a failure to read the file was displayed. Medtronic navigation was aborted. The patient impact related to the event was not clear at the time of the report. There was a reported delay to the procedure of less than 1 hour due to this issue.
 
Manufacturer Narrative
Additional information: there was no impact on patient outcome. The surgeon opted to complete the procedure without the use of the imaging system. The surgeon opted to complete the procedure without the use of the navigation system.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the issue could not be replicated. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION S7 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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7654152
MDR Text Key112845153
Report Number1723170-2018-03050
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00643169505742
UDI-Public00643169505742
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2015
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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