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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 Patient Involvement (2645)
Event Date 04/20/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The representative noted that the new database installed would not allow any of the applications to work. The computer was replaced. The navigation system then passed the system checkout and was found to be fully functional. The suspected computer was returned for analysis, however, results are not yet available.
 
Event Description
Medtronic received information regarding a navigation device being used outside of a procedure. It was reported that after updating the tools database on the navigation system, for the site's microscope bracket, the system would unexpectedly exit when they would go to select the microscope type in the software. 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
Further review found that the reported event was related to an administrative service activity outside of a clinical setting, and the reported issue was unlikely to cause serious harm to a patient or user. The initial mdr was submitted in error, and the reported event should not have been considered a reportable malfunction.
 
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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
amos jarrette
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208903200
MDR Report Key7521441
MDR Text Key108484205
Report Number1723170-2018-02100
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 08/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2011
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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