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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 Problems Environmental Compatibility Problem (2929); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 03/02/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluation has not been done at the time of submitting this report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar procedure. It was reported that the system was taking screen shots without anyone touching the system. The system then powered off unexpectedly. The site powered the system back on and the system functioned as intended with no other issues. The clinical specialist (cs) tried to recreate the issue outside of the surgery but was unable to. There was a procedure delay of less than one hour and no impact to the patient. It was reported that the system powering off could have been a result of someone inadvertently stepping on the power cord and it pulling from the wall socket but no one could confirm that. It was confirmed that the system was plugged into a known good outlet. Other items were also plugged into the same outlet with no issues.
 
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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 Key9865623
MDR Text Key184469658
Report Number1723170-2020-01011
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
Report Date 03/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2020
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 Received03/02/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/21/2019
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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