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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Unique device identification(udi) is not available. Device manufacturing date is unavailable. A medtronic representative went to the site to test the equipment. Testing revealed that the issue could nor be replicated.
 
Event Description
Medtronic received information regarding a navigation device that the issue occurred preoperative while setting up for a procedure. It was reported that the system exited out of the software while loading a disk. The site decided not to use the navigation device for the subsequent procedure. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided.
 
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
7208902515
MDR Report Key7643032
MDR Text Key112553457
Report Number1723170-2018-03022
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,Followup
Report Date 08/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2018
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 Received08/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2013
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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