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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 No Display/Image (1183); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. The system computer was returned to the manufacturer for analysis. Analysis found that there was a bad sector in the hard drive. Analysis found that the reported event was related to a computer component issue. A medtronic representative went to the site to test the equipment. Testing revealed that both monitors were not working. Replaced the system commuter. Systems checkout was performed and system was functioning as intended.
 
Event Description
Medtronic received information regarding a navigation device being used outside of procedure. It was reported that the system boots up but there was no signal to both monitors. No patient present.
 
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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
jack edell
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7596688
MDR Text Key110910939
Report Number1723170-2018-02748
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeNL
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
Report Date 06/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2018
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? Yes
Date Device Manufactured01/10/2012
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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