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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S7 SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S7 SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9734056
Device Problem Mechanical Problem (1384)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 10/25/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used pre-operatively of a cranial anchorage procedure. It was reported the system had to abort navigation during surgery. It was noted that the original procedure was supposed to be a cranial anchorage, but had to switch to craniotomy due to navigation being aborted. This issue occurred after anesthesia has been administered, but before any incision has been made. The procedure was completed without the use of navigation. There was a less than 1-hour delay to the procedure.
 
Manufacturer Narrative
Analysis on the returned monitor resulted in no failure being found through functional testing and visual/physical examination. Analysis on the returned uninterruptible power supply (ups) resulted in no failure being found through functional testing and visual/physical examination. Analysis states that the ups was able to power up and run from battery power and recharge a known good battery. Analysis on the returned polaris spectra resulted in no failure being found through functional testing, visual/physical examination, and proceduralized device testing. Analysis states that the polaris spectra passed an accuracy test at. 25 mm with a passing threshold of. 35 mm. No problem found. Analysis on the returned polaris spectra system control unit (scu) resulted in no failure being found through functional testing and visual/physical examination. Analysis states that the event logs did not reveal any adverse events. No problem found. Analysis on the returned field generator resulted in no failure being found through functional testing and visual/physical examination. Analysis states that it was connected to a test system for a multi-day burn-in and it remained in green testing. Fully functional. Analysis on the returned axiem unit resulted in no failure being found through functional testing and visual/physical examination. Analysis states that it was connected to a test system for a multi-hour burn-in test. No failure found. Analysis on the returned monitor cable resulted in no failure being found through functional testing and visual/physical examination. Analysis states that the cable passed continuity test with no opens or shorts detected. Analysis on the returned axiem power/data cable resulted in no failure being found through functional testing and visual/physical examination. Analysis states that the cable passed continuity test with no opens or shorts detected. No problems found. Analysis on the returned power supply resulted in no failure being found through functional testing and visual/physical examination. Analysis states that all outputs measured in the normal range. No problems found. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Correction: a medtronic representative tested the computer and testing determined there were no malfunctions with the computer. The system then passed the system checkout and was found to be fully functional. A second battery for the navigation system was returned to the manufacturer for analysis. The battery was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. Analysis on the returned on/off switch cable resulted in no failure being found through functional testing and visual/physical examination. There were no problem found. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional analysis.
 
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Brand NameNAVIGATION STEALTH STATION S7 SYSTEM
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 Key8089492
MDR Text Key128042312
Report Number1723170-2018-05751
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734056
Device Catalogue Number9734056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2018
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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