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

Model Number UNK_NAV_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: unk_nav_comp, serial/lot #: unknown.Patient information was not included in the journal entry.Age) this value reflects the average age of the patients who underwent bilateral surgery for placement of electrodes for stereotactic electroencephalography (seeg), as specific patients could not be identified.Date of event) please note that this date is based off of the date of publication of the article, as the event dates were not provided in the published literature.Event) the article citation is included.The system product number and serial number were not provided in the journal article.The 510k is not provided as the system is unknown.Device evaluated by mfr) no evaluation was performed as the event was reported in a literature article.Device manufacturing date is unavailable.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.

Event Description

Citation: tay, angelique sao-mai, et al.¿placement of stereotactic electroencephalography depth electrodes using the stealth autoguide robotic system: technical methods and initial results.¿ operative neurosurgery, vol.22, no.4, 2022, https://doi.Org/10.1227/ons.00000000 00000110.Summary object: to describe the technical methods for insertion of seeg using the medtronic stealth autoguide robotic system and detailed outcomes in the initial 9 patients implanted methods: nine patients underwent placement of electrodes for seeg studies with the use of the autoguide system.Patients had at least 10 electrodes placed.Targets were planned on a stealth s8 planning station, and electrodes were placed under general anesthesia.A technique for placement is described in detail.Patient outcomes and accuracy of electrode placement were evaluated.Methods to improve accuracy were investigated.Comparison of postoperative mris with preoperative planning mris was performed to determine the accuracy of electrode placement.Results: one hundred two electrodes were placed in 9 patients.Methods for placement and technical nuances are detailed.The distance from the planned target to the actual position of the electrode tip was measured in 8 of the 9 patients.The mean euclidean distance was 4.67 ± 0.27 mm.There was 1 placement-related hemorrhage deficit in the first patient, and no deaths or infections.Adequate positioning of electrodes for seizure monitoring was obtained in all patients.Conclusion: autoguide can be used for placement of electrodes for seeg studies with acceptable degrees of patient safety, accuracy, and efficiency.Considering the cost of autoguide compared with other robotic devices, it may be attractive option.Reported event: nine patients underwent bilateral surgery for placement of electrodes for stereotactic electroencephalography (seeg) studies with the use of the autoguide system.There was one postoperative intraparenchymal hemorrhage in the first patient implanted.The patient emerged from anesthesia with left-sided hemiplegia and was taken back for hematoma evacuation.Three of his 10 electrodes were removed.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15227248
• MDR Text Key: 297912021
• Report Number: 1723170-2022-01296
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• 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: 36 YR
• Patient Sex: Male