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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 Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 12/19/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. After changing the power cord a few days ago, i had a power cycling issue with the computer. I was sent a new computer. After installing new computer, i installed software applications. Tested loading patient scans via cd to test how 3d models would look under each application. Also checked communication with tracking system. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The computer was returned to the manufacturer for analysis. The device was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Event Description
A medtronic representative reported that after replacing the damaged cable, the computer no longer powered on consistently. Computer turns on, and then turns off shortly thereafter. During troubleshooting with call center, they check the connections and test multiple outlets on the uninterruptible power supply (ups). The rep also connected the power to a wall outlet directly and issue persisted. There was no patient present when this issue was identified.
 
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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
826 coal creek circle
attn:product quality experienc
louisville, CO 80027
7208902082
MDR Report Key7201878
MDR Text Key97801064
Report Number1723170-2018-00263
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 01/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2009
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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