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

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problems Hematoma (1884); Paralysis (1997)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier not available from the site.Patient age not available from the site.Patient weight not available from the site.A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system used alongside the automated trajectory guidance unit was found to be fully functional.The navigation system then passed the system checkout and was found to be fully functional.Other relevant device(s) are: product id: 29631, serial/lot #: unknown, ubd: , udi#: if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system and automated trajectory guidance unit being used during a stereoelectr oencephalography (seeg) procedure.It was reported that the patient experienced an intradural hematoma intra-operative and the procedure was subsequently changed.It was later reported that the issue was suspected to have been caused by an inaccuracy of navigation.Following patient registration, it was noted that the accuracy was checked and found to be accurate.During the procedure, it was noted that a biopsy needle was used to place an electrode hole for the seeg and the seeg needle was inserted free-handed.It was reported that the non-medtronic headframe and automated trajectory guidance unit could not be set, subsequently the units were set on the side bed rail of the operating table, and the subsequent usage was not recommended by the manufacturer.The workflow was reported to have begun with a puncture with the biopsy needle to gain entry into the brain, the guidance unit and navigation were then performed, the electrode was subsequently placed via fluoroscopy.It was noted that the electrode was then inserted into the hole, where fluoroscopy found the unit was slightly below the hole made by the biopsy needle.The physician found that the electrode entered the lower portion as there was no electrode stiffness at the time.The electrode was removed and inserted into the outer cylinder of the electrode.Once the electrode was confirmed to have no bends, the surgeon inserted the electrode into the anatomy with the hole the biopsy needle had generated and the hematoma occurred.It was later reported that upon discovery of the hematoma via computed tomography (ct) imaging, the procedure was updated to a craniotomy.An additional craniotomy was noted to have been performed on the subsequent day where it was also noted that the patient was paralyzed and it was noted there was potential the paralysis could be permanent.

Manufacturer Narrative

Concomitant products: pn: 29631, ln/sn: (b)(6).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.

Manufacturer Narrative

The software team investigated the reported issue.The logs and archives were not available.There was insufficient information to determine whether a software anomaly contributed to the reported behavior.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: STEALTHSTATION S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12032077
• MDR Text Key: 257145497
• Report Number: 1723170-2021-01640
• Device Sequence Number: 1
• Product Code: HAW
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• 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: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention