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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The navigation system then passed the system checkout and was found to be fully functional. No parts have been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation device being used for a cranial resection procedure. It was reported that the site was registering and the system flickered and booted out to the blue screen. The system was shut down and the site proceeded. The registration was saved and there was no delay. There was no reported impact on patient outcome.
 
Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue through known anomaly determination. Analysis 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 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 Key7497787
MDR Text Key107691443
Report Number1723170-2018-01944
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2012
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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