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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 09/23/2019
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 9733619, serial/lot #: (b)(4). Device udi number unavailable. A medtronic representative (rep) went to the site to test and service the equipment. The computer was replaced but the monitors were still black. The rep noted that he noticed a damaged digital visual interface (dvi) to video splitter cable. The rep performed further troubleshooting. The video splitter was not receiving power. The system control unit (scu) light was on and receiving power indicating the uninterruptible power supply (ups) was functional. The rep re-sat the connection from the multi-out power supply to the ups and swapped to different ac power out. However, the fans were not running on the back of the multi-out power supply. Thus, the multi-out power supply was replaced. The system then passed the system checkout and was performing as intended. The computer was returned but was under analysis at the time of filing. The multi-out power supply was returned for hardware analysis. Visual/physical examination and functional testing were performed, and the reported issue was able to be duplicated. When connected to ac all ports had no output with the exception of the 28vdc port which had normal output. It was determined that there was an electrical failure with the multi-out power supply. This issue was documented in a medtronic navigation hardware anomaly tracking database. Device manufacturing date unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a cranial resection. It was reported that after registration, both monitors went black and did not display a message. Several attempted reboots did not resolve the issue. The patient was present when this occurred. Navigation and medtronic imaging were aborted. Additionally, the site opted to abort the surgery. Anesthesia was administered prior to aborting the procedure, but an incision was not made prior to aborting the procedure. There was no impact on patient outcome, and the patient did not experience any symptoms related to this event. There was a surgical delay of less than 1 hour. It was noted that the surgery was rescheduled for the following day.
 
Manufacturer Narrative
The computer was returned for analysis. Functional testing determined that the computer was functioning as designed. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION 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 Key9182563
MDR Text Key166180822
Report Number1723170-2019-05202
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
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? Yes
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 Manufacturer10/04/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/11/2019 Patient Sequence Number: 1
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