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 Problem Insufficient Information (4580)

Event Date 09/10/2022

Event Type  Injury  

Event Description

Citation: muscas, g., orlandini, s., bonaudo, c., dardo, m., esposito, a., campagnaro, l., carrai, r., fainardi, e., ciccarino, p., <(>&<)> della puppa, a.(2022).Functional outcomes, extent of resection, and bright/vague fluorescence interface in resection of glioblastomas involving the motor pathways assisted by 5-ala.Acta neurochirurgica, 164(12), 3267¿3274.Https://doi.Org/10.1007/s00701-022-05358-9 summary: background: 5-aminolevulinic acid (5-ala) fluorescence can maximize perirolandic glioblastoma (gbm) resection with low rates of post operative sequelae.Our purpose was to present the outcomes of our experience and compare them with other literature reports to investigate the potential influence of different intraoperative monitoring strategies and to evaluate the role of intraoperative data on neurological and radiological outcomes in our series.Methods: we retrospectively analyzed our prospectively collected database of gbm involving the motor pathways.Each patient underwent tumor exeresis with intraoperative 5-ala fluorescence visualization.Our monitoring strategy was based on direct stimulation (ds), combined with cortical or transcranial meps.The radiological outcome was evaluated with cret vs.Residual tumor, and the neurological outcome as improved, unchanged, or worsened.We also performed a literature review to compare our results with state-of-the-art on the subject.Results: sixty-five patients were included.Cret was 63.1%, permanent postoperative impairment was 1.5%, and ds¿s lowest motor threshold was 5 ma.In the literature, cret was 25¿73%, permanent postoperative impairment 3¿16%, and ds lowest motor threshold was 1¿3 ma.Our monitoring strategy identified a motor pathway in 60% of cases in faint fluorescent tissue, and its location in bright/faint fluorescence was predictive of cret (p<(><<)>0.001).Conclusions: based on the data presented and the current literature, distinct monitoring strategies can achieve different onco-functional outcomes in 5-ala-guided resection of a glioblastoma (gbm) motor pathway.Intraoperatively, functional and fluorescence data close to a bright/vague interface could be helpful to predict onco-functional outcomes.Reported event: sixty-five patients underwent a tumor resection procedure.One patients neurological status worsened post-operatively.See attached literature article.

Manufacturer Narrative

A1-a5) patient information was not included in the journal entry a2) this value reflects the mean age of the patients who underwent the tumor resection as specific patients could not be identified.A3) this value reflects the majority gender of the patients who underwent the tumor resection as specific patients could not be iden tified.B3) the article did not provide the date of the procedure.The event date provided is the published date.B5) the article citation is included.D4) the system product number and serial number were not provided in the journal article.Udi not available for this system.G2) no 510k provided as system is unknown.H3) no evaluation was performed as the event was reported as a literature article.H4) 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.

• 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: 18283322
• MDR Text Key: 329947683
• Report Number: 1723170-2023-02676
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/07/2023
• 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): Other
• Patient Age: 57 YR
• Patient Sex: Female