MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 PREMIUM STEALTHSTATION; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 06/24/2020

Event Type  Death  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system functioned as designed and the imprecision could not be replicated.The system then passed the system checkout and was found to be fully functional.Other relevant device(s) are: product id: 9735740, serial/lot #: (b)(4).Mdr is related to mdr 3004785967-2020-00753.Mdr is in relation to the medtronic imaging system in the procedure.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while in posterior t4-pelvis spinal fusion, the right illiac screw was placed inaccurately.It was reported that the screw was the first navigated screw being placed.Additionally, the misplaced screw was placed with an unknown magnitude of inaccuracy and that the patient suffered from bleeding due to the screw.The surgeon opted to complete the procedure without the use of the navigation system.There was a reported delay to the procedure of less than 1 hour due to this issue.It was later reported that the patient had passed away.Additional information was received.It was reported that no inaccuracy was observed following registration.It was noted that the facility was uncertain if accuracy was checked following registration.It was noted that the pedicle hole prep and screw navigation was performed with a straight tactile awl with a medtronic instrument tracker.Additionally, the reference fame was placed on a thoracic clamp.It was reported that remaining screws were placed with navigation.Additional information was received stating that the trajectory images were similar, which led to minor confusion that did not affect screw placement.It was suspect that the bleeding occurred after drilling and tapping occurred prior to insertion of the last iliac screw.

Manufacturer Narrative

H3) a software analysis was initiated as part of the investigation.Analysis found that there was evidence of reference frame movement, following an initial image acquisition and prior to the screw being placed.The distance between in the surgical site and the reference frame indicated, that frame movement was suspected to have caused the inaccuracy.And that there was insufficient information to determine the relationship of the software to the reported issue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr, parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: S8 PREMIUM STEALTHSTATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10247432
• MDR Text Key: 198012689
• Report Number: 1723170-2020-01866
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000272739
• UDI-Public: 00763000272739
• Combination Product (y/n): N
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10"
• Patient Outcome(s): Death
• Patient Age: 32 YR
• Patient Weight: 32