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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 PREMIUM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC S8 PREMIUM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2020
Event Type  malfunction  
Manufacturer Narrative
This was reported under a imaging system regulatory report #: 3006544299-2020-00117. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported outside of a procedure that the midas had intermittent navigation. No patient was present at the time of the event. Additional information was received stating that there was a 10 minute delay in the case. There was no impact on patient outcome. They navigated a gear shift in lieu of the drill. The communication between the imaging system and the navigation system were fine. The midas was not being seen by the camera. Some troubleshooting was done to fix the issue, but in the interest of minimizing delay, and with other tools on the table that navigated accurately, the health care professional moved on. The issue may have been user error or situational. The site used a different instrument to complete the case.
 
Manufacturer Narrative
Additional information received from a manufacturer representative reported the correct patient information. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information was received from the manufacturing representative that after the case, she had checked out the drill and it navigated without issue. The navigation system performed as intended and passed a system checkout. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameS8 PREMIUM
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 Key10000912
MDR Text Key189339613
Report Number1723170-2020-01301
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
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 05/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2019
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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