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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 Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2017
Event Type  malfunction  
Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative. The network cable on the i/o panel failing to receive exams. The network port was replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Correction: supplemental report 001 of this occurrence inadvertently filed. Information filed under 1723170-2019-01509. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: a software investigation analysis was initiated to determine the probable cause of the issue through log analysis. Analysis found that the analysis was inconclusive and probable cause was unable to be determined. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Patient weight not available from the site. A medtronic representative inspected the navigation system onsite and found that after taking the imaging system spin and in the spine software, the x-ray images were black on the navigate screen on the staff cart, but they showed up on the surgeon monitor. After rebooting the navigation system it was possible to send over the same exam and see the x-ray images again on the staff monitor. No parts were replaced or returned to the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while in a sacroiliac and thoracolumbar procedure, there was an image transfer issue with the navigation system. The images that were sent over from the imaging system showed up on the staff cart monitor black. The images showed up fine on the staff cart monitor and other monitors in the operating room (or). There was no delay to the case as a result of this issue and no impact on the patient outcome. After the case, the system was rebooted and it was possible to see the patient images.
 
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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
stephanie riley
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7184157
MDR Text Key131810681
Report Number1723170-2018-00197
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2018
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2010
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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