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

Model Number 9733856

Device Problem Computer Software Problem (1112)

Patient Problem Brain Injury (2219)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Patient demographic information was refused by the site.No parts have been received by the manufacturer for evaluation.Medwatch mw5087195.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in an electrode and probe placement procedure (deep brain stimulation (dbs) procedure).It was reported that during stimulation of the microelectrode the patient was having response on the right side of his body when there should have been responses on the left side of his body.Discussions were held between the neurologist and the neurosurgeon.During discussions, it was noted that on the navigation system the system showed they were in navigation mode for the right side of the body and not the left.But when they switched back to the planning screen on the navigation system, the system switched the screen to the left side of the body.They were able to replicate this issue multiple times, and there were multiple attempts to troubleshoot without success.The procedure was aborted due to safety concerns to the patient.The neurosurgeon ordered a ct scan stat for the patient and then when to the recovery room.The ct scan noted blood and free air in the patient's third ventricle.The alleged inaccuracy was noted with a 5mm difference between plan 1 and plan 2 of navigation.There was a delay to the procedure of less than an hour.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The imaging system passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Software analysis through design analysis revealed that the software was functioning as designed.The behavior described is the intended behavior of the software.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: 8732063
• MDR Text Key: 149115330
• Report Number: 1723170-2019-03811
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 07/03/2019; 08/16/2019
• Supplement Dates FDA Received: 08/02/2019; 08/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• 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