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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 Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 03/01/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to site to test the equipment. Representative reported that the system was power cycled multiple times. Power and communication connections within the navigation system were checked. Axiem was swapped from other navigation system but the issue could not be replicate the issue. As a precaution, axiem box was replaced. Instruments and trackers were operating as intended. No communication failures. 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 axiem box has been received by the manufacture for evaluation. The returned axiem was not functional. Eminterface shows multiple power supply fault codes. 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.
 
Event Description
A medtronic representative reported that while outside of procedure, the site was having a intermittent axiem communication with navigation system. It was reported that the power light on the axiem box was on but the navigate light was off and fault light was not lit. Set up equipment displayed an orange line connecting the axiem and navigation system. Representative could not confirm the number on the back of the axiem box. During troubleshooting, the system was unplugged/replugged and rebooted multiple times and the site was able to restore connection to the axiem box and proceeded with setting up for the case. There was no patient present at the time of the issue.
 
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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 Key7366812
MDR Text Key103343082
Report Number1723170-2018-01287
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 03/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2018
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 Manufacturer03/08/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2013
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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