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 Abscess (1690); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Respiratory Failure (2484)

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

B3.Please note that this date is based off the date of publication of the article as the actual event date was not provided.A2.Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.A3.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.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.

Event Description

Peter schulliana, edward johnstonb, gregor laimera, daniel putzera, gernot eberlea, philip westerlunda , benjamin henningerc and reto bale.Thermal ablation of ct ¿invisible¿ liver tumors using mri fusion: a case control study.International journal of hyperthermia.1 (2020).Doi: 10.1080/02656736.2020.1766705 abstract purpose: to evaluate whether ¿invisible¿ liver tumors on ct can be treated by stereotactic radiofrequency ablation (srfa) using fusion of pre-ablation mri.Methods: in this retrospective case¿control study, 60 patients (14 with hepatocellular carcinoma (hcc) and 46 with metastatic liver tumors) with ct ¿invisible¿ lesions underwent srfa using mri-fusion between june 2005 and june 2018 (¿fusion group¿).For comparison, 60 patients who underwent srfa without image fusion were selected using nearest neighbor propensity score matching (¿control group¿).Endpoints consisted of local tumor control, safety, overall and disease-free survival.Results: major complications occurred in 6/69 ablations (8.7%) in the fusion group and in 6/89 ablations (6.7%) in the control group (p ¼ 0.434).Primary technical efficacy rate (i.E., successful initial ablation) was 96.6% (28/29) for hcc and 97.9% (166/170) for metastatic disease in the fusion group and 100% (33/33) and 93.3% (184/194) in the control group, respectively (p ¼ 0.468 and 0.064).Local recurrence (lr) was observed in 1/29 (3.5%) hccs and in 6/170 metastases (4.0%) in the fusion group and 1/33 (3.0%) and 21/196 (10.7%) in the control group, respectively.The lr rate of metastasis in the control group was significantly higher (p ¼ 0.007), although differences in os and dfs did not reach statistical significance.Conclusions: image fusion using pre-procedural mri allows for ablation of ct-¿invisible¿ liver tumors that are otherwise untreatable.Moreover, local oncological control was higher in metastatic liver tumors versus matched controls which suggests it could be useful tool for all stereotactic radiofrequency ablation procedures.Reported events - in the fusion group, overall major complication rate was 8.7% (6 of 69 ablations), with 7.1% (1 of 14 ablations) for hcc patients and 9.1% (5 of 55 ablations) in patients with metastatic disease.Three patients developed perihepatic hemorrhage which was managed by angiographic coiling.Two pneumothoraces and one massive pleural effusion required treatment with chest tubes.Five of six major complications were successfully treated by the interventional radiologist in the same anesthetic session.The median hospital stay after srfa was 4.5 days, ranging from 2 to 35 days.In the control group, overall major complication rate was 6.7% (6 of 89 srfa sessions) for hcc patients 5.9% (1 of 17 ablations) and 6.9% (5 of 72 ablations) for patients with metastatic disease.Complications comprised a liver abscess, intra-/perihepatic hemorrhage (3 patients), a pneumothorax and a pleural effusion.

Manufacturer Narrative

Additional information was added to 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

The health care professional stated that "i herewith confirm that none of the complications reported in the paper are related to malfunctioning of any medtronic product.".

• 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: 18662835
• MDR Text Key: 334832630
• Report Number: 1723170-2024-00471
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 02/08/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male