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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 Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Date 05/15/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Unique device identification (udi) is unavailable. Device manufacturing date is unavailable. A medtronic representative went to the site to test the equipment. Testing revealed that the internal and external monitor cables and power supply box were not functioning as designed. Replacing the parts resolved the issue. The system then passed the system checkout and was found to be fully functional. The parts have not been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation device being used outside a procedure. It was reported that the surgeon monitor was black status, no signal or power. The site representative reported an odor indicating possible electrical overstress. There were no issues with the video signal going to the staff cart monitor. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided. The monitor cable was returned to the manufacturer for analysis. The cable was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. The external monitor cable was returned to the manufacturer for analysis. The cable was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. The monitor for the navigation system was returned to the manufacturer for evaluation. Testing found that the stand off nut was removed from the video connector. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database. The power supply for the navigation system was returned to the manufacturer for evaluation. Testing found that the 28 vdc port had no output. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware 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 Key7594067
MDR Text Key110848387
Report Number1723170-2018-02737
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
Type of Report Initial,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
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 Manufacturer07/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2011
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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