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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 Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 06/08/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Onsite functional and visual examination was performed by a manufacturer representative. No parts were replaced and no issue was found with the device. The system passed a system checkout.
 
Event Description
Medtronic received information regarding a navigation device being used outside a procedure. It was reported that the system became unresponsive and was rebooted with resolve. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Logs were reviewed for this event. The issue was unable to be determined without additional information. If information is provided in the future, a supplemental report will be issued.
 
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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
parker desautel
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7664714
MDR Text Key113265851
Report Number1723170-2018-03160
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
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 12/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2018
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? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2013
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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