MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Infarction, Cerebral (1771); Spinal Column Injury (2081)

Event Date 04/15/2018

Event Type  Injury  

Manufacturer Narrative

Patient information not provided due to japanese patient privacy regulations.Udi not available for this system at time of filing.Device manufacturing date is not available for this system at time of filing.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation system being used in a cervical c5/6 (cervical laminoplasty) spine fusion procedure.It was reported that there was an alleged inaccuracy observed after the screw was inserted in the c5 on the left.3d images were taken with an imaging system and the issue had apparently resolved.However, it was reported that all the screws were inserted in the arterial ventricle at 50-70%.Surgical revision was required.On the second day post procedure, the patient experienced cardiopulmonary arrest as decreased blood flow caused the brain to swell and the brain stem to be pressed.The patient was revived and cerebral decompression was performed on the 3rd day post procedure.Blood was flowing from another vessel.The patient then reportedly fell down the stairs causing a cervical dislocation.A brain infarction occurred, however it was not known if it was due to the fall or the screws being inserted in the vertebral artery.

Manufacturer Narrative

Additional information: device manufacture date provided.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the system was performing as intended.The 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.

Event Description

Medtronic received additional information that it was noted that a contributing factor to the issue was the movement of the reference frame.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7515182
• MDR Text Key: 108288599
• Report Number: 1723170-2018-02046
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2013
• 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; Disability