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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problems Mechanical Problem (1384); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2020
Event Type  malfunction  
Manufacturer Narrative
Other applicable components are: product id: 9735225r, serial/lot #: unknown; product id: 9733686, version: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure. It was reported that the site was having issues with the spine software. When taking a navigated spin with the imaging system and transferring, the spine software exited and the system became intermittent. A manufacturing representative was only able to get to the select surgeon screen before the system exited again. Another system was attempted to be used and the same issue occurred (this system was captured in a separate case). Troubleshooting was performed by trying another outlet and trying an uninstall-reinstall of the software. This did not resolve the issue as the software would still exit and the system became unresponsive. There was a 1 hour or longer delay to the procedure and no impact to patient outcome.
 
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Brand NameSTEALTHSTATION S7
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9553726
MDR Text Key184506131
Report Number1723170-2020-00044
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
Report Date 02/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2015
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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