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 Hemorrhage/Bleeding (1888); Paresis (1998); Cognitive Changes (2551); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 03/04/2023

Event Type  Injury  

Manufacturer Narrative

G2: this event occurred in japan, see e1-e3.H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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: brain sci.2023, 13, 440.Https://doi.Org/10.3390/brainsci13030440.Summary: stereotactic electroencephalography (seeg) is an epoch-making method of depth electrode insertion for intracranial eeg evaluation in epilepsy surgery and has recently spread worldwide as a key method of intracranial eeg evaluation [1¿5].Depth electrodes can evaluate deeper parts of the brain such as insula, operculum, and cingulate gyrus compared with subdural electrodes which are implanted to cover some part of the brain surface.The complication rate from seeg has been thought to be low, but hemorrhagic complications are reported in 19.1% of patients and symptomatic hemorrhaging in 2.2% [6].Another study summarized complication rates by three hemorrhagic types: epidural hemorrhage (0.3%), subdural hemorrhage (0.4%), and intraparenchymal hemorrhage (0.7%) [7].Therefore, surgeons should not ignore the possibility of hemorrhagic complications.Here, we report an unusual case of intraparenchymal hemorrhage in seeg.Pre- and postoperative evaluations supported the hemorrhage being caused by an indirect injury to the adjacent artery after the arachnoid trabeculae was stretched by the puncture needle.Reported event(s): this article is a case study of a 20-year-old male with focal impaired awareness seizure, sometimes progressing to secondary generalized seizures with his neck rotated to the right side.After seeg implantation, the patient experienced moderate disturbance of consciousness and right hemiparesis.Ct showed an intraparenchymal hemorrhage and a subarachnoid hemorrhage.The latter was located around the electrode inserted.A procedure to perform hematoma evacuation was done.After this procedure, the patient recovered well regarding his consciousness and hemiparesis, but developed an aneurysm.A postoperative mild deviation of the running course of the middle cerebral artery (mca) was identified.It was noted that the cause of the hemorrhage may have been an indirect injury to the mca.Another procedure was performed for the aneurysm.

Event Description

Additional information was received.It was reported that the adverse events reported in this article were not related to any medtronic devices.

Manufacturer Narrative

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: 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: 18220734
• MDR Text Key: 329159474
• Report Number: 1723170-2023-02423
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 12/08/2023
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization