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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 Mechanical Problem (1384); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to site to test the equipment. Representative reported that a polaris spectra system control unit (scu)to positioning sensor unit (psu) cable was replaced. A system checkout was performed and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The suspect cable has been received by the manufacturer for evaluation. The returned cable was found to be in good condition and passed continuity test with no opens. No fault found.
 
Event Description
A site representative reported that during cranial resection, the camera of the navigation system would intermittently switch to localizer not connected. Site was able to get the system to a good position and complete the case. During troubleshooting, representative checked connections. When the localizer disconnected the lights on the camera stays on. Checked the cable for cuts but could not reproduce the issue. Camera arm was moved. Ndi toolbox showed no errors. The procedure was completed with the use of navigation. There was no delay to procedure. No known impact on patient outcome.
 
Manufacturer Narrative
Other relevant device(s) are: product id: 9733575, serial/lot #: (b)(4), ubd: unknown, udi# unknown. The device codes are now applicable upon further review. 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
prashanth gali
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7397554
MDR Text Key104412211
Report Number1723170-2018-01444
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2018
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 Manufacturer03/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2012
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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