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

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.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: INSTRUMENT, 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 Key: 9182563
• MDR Text Key: 166180822
• Report Number: 1723170-2019-05202
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Date Manufacturer Received: 10/23/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 68