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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Patient Involvement (2645)
Event Date 11/11/2016
Event Type  malfunction  
Manufacturer Narrative
Return requested. Replacement computer shipped to site (b)(6) 2016. Medtronic investigation of returned suspect computer finds that the navigation system powers on, post's and boots normally. Application launch and navigate performed as expected. No performance issues encountered. Hdd and ram report no errors. Navigation system passed all required testing. No fault found. Return requested. Replacement positioning sensor unit (psu) shipped to site (b)(6) 2016. Medtronic investigation of returned suspect device finds that the psu was returned with many nicks and scratches. The psu powered up without the fault light illuminated. The psu passed an aak test at. 14 mm with a passing threshold of. 35 mm. System fault code - illuminator current out of range. Electrical failure. Hardware investigation was completed. This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database. No further issues have been reported.
 
Event Description
A medtronic representative received a report that a site's navigation system software exited unexpectedly. The medtronic representative noted the camera error light appears and coincides with the software exiting. The medtronic representative uninstalled/reinstalled software which appeared to resolve the issue, however, the behavior had reoccurred. No further details regarding the behavior, or specifically when it occurred, were provided. 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
judith ericson
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6158149
MDR Text Key61888990
Report Number1723170-2016-05672
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2016
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 Manufacturer11/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2011
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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