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 Muscle Weakness (1967); Unspecified Nervous System Problem (4426); Partial Hearing Loss (4472); Swelling/ Edema (4577)

Event Date 01/09/2022

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the mean age of the patients who underwent a lateral lumbar interbody fusion as specific patients could not be identified.This value reflects the majority gender of the patients who underwent a lateral lumbar interbody fusion as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the accepted online date.The article citation is included.The system product number and serial number were not provided in the journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as the event was reported as 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

Patel, p.D., ashraf, o.; danish, s.F.(2022).Magnetic resonance-guided laser interstitial thermal therapy for brainstem pathologies.World neurosurgery, 161.Https://doi.Org/10.1016/j.Wneu.2022.01.040.Summary objective: magnetic resonance-guided laser interstitial thermal therapy (mrglitt) is a minimally invasive and effective treatment option that can potentially treat deep seated pathologies in cases without safe open surgical corridors.In the present report, we have described our experience using mrglitt for brainstem pathologies.Methods: a retrospective medical record review and analysis were conducted for all patients who had undergone mrglitt for pathologies within or closely surrounding the brainstem between 2011 and 2020.The patients had undergone stereotactic laser placement in the operating suite and were transported to the magnetic resonance imaging suite for laser ablation with real-time monitoring.The demographics, operative parameters, and complications were recorded.Results: a total of 12 patients had undergone mrglitt for brainstem pathologies.The average age of the patients was 47.6 years (range, 4e75 years).The pathologies included both primary and metastatic intracranial tumors.The average preablation volume of the targets was 2.4 +/- 0.50 cm3.The average ablation time was 324.3 +/- 60.7 seconds, and the average postablation volume was 2.92 +/- 0.53 cm3.One perioperative mortality was directly related to the procedure and 7 patients developed postoperative deficits.Two patients had experienced a recurrence after mrglitt and opted to undergo additional alternative treatment.Conclusions: the brainstem represents formidable territory even for minimally invasive procedures.The overall morbidity and mortality has remained high, and the probability of achieving a meaningful outcome must be carefully assessed.Reported event twelve patients with a histology of deep-seated intracranial tumors underwent magnetic resonance-guided laser interstitial thermal therapy.One patient experienced a refractory edema.Seven patients had experienced new or worsening cranial nerve deficit, which mostly consisted of hearing loss and/or facial weakness.Two patients experienced resolution, but five patients did not during their most recent follow up.Finally, one patient experienced dysdiadochokinesis, which had shown partial improvement at follow-up.

• 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: 14957380
• MDR Text Key: 295498465
• Report Number: 1723170-2022-01049
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• 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: 07/05/2022
• 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): Other
• Patient Age: 48 YR
• Patient Sex: Female