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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 Display or Visual Feedback Problem (1184); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information: the surgeon opted to complete the procedure without the use of the navigation system. The computer for the navigation system was returned to the manufacturer for evaluation. It was noted that the ram modules were not returned with the unit. It was noted that the test modules were installed and the unit functioned as designed. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
Manufacturer Narrative
Patient information not provided due to canadian patient privacy regulations. A medtronic representative went to the site to test the equipment. The representative reported that the issue was occurring intermittently. Troubleshooting of the video connection cables and connectors did not restore functionality. It was then reported that the computer of the navigation system was replaced to restore functionality. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. No parts have been received by the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that, while in a cranial resection, the monitors on the navigation system were intermittently losing functionality in a "flickering" manner. It was reported that the display was distorted during the flickering. Following the procedure, it was reported that the issue could not be replicated. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no known impact on patient outcome.
 
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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 Key7215939
MDR Text Key115806259
Report Number1723170-2018-00310
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,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
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 Received07/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2017
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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