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 Necrosis (1971)

Event Date 01/04/2022

Event Type  Death  

Manufacturer Narrative

A2) patient age is the mean value of patients in the study.A3) patient gender is the majority value of patient in the study.A4) patient weight not available from the site.B3) event date is the online publishing date of the literature article.D4) device lot number, or serial number, unavailable.G4) 510(k) is dependent upon the device model number and therefore, unavailable.H3,h6) no parts have been received by the manufacturer for evaluation.H4) device manufacturing date is dependent on lot number/serial number, therefore, 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

Braunwarth, e., schullian, p., kummann, m., reider, s., putzer, d., primavesi, f., stattner, s., ofner, d., bale, r.Aggressive local treatment for recurrent intrahepatic cholangiocarcinoma¿stereotactic radiofrequency ablation as a valuable addition to hepatic resection.Plos one 17(1): e0261136.Https://doi.Org/10.1371/journal.Pone.0261136 background to evaluate the efficacy, safety and overall clinical outcome of local treatment for recurrent intrahepatic cholangiocellular carcinoma after hepatic resection.Methods between 2007 and 2019 72 consecutive patients underwent hepatic resection for primary intrahepatic cholangiocellular carcinoma.If a menable, recurrent tumors were aggressively treated by hr or stereotactic radiofrequency ablation with local curative intent.Endpoints consisted of morbidity and mortality, locoregional and de novo recurrence, disease free sur-vival, and overall survival.Results after a median follow-up of 28 months, recurrence of intrahepatic cholangiocellular carci-noma was observed in 43 of 72 patients und ergoing hepatic resection (60.3%).16 patients were subsequently treated by hepatic resection (n = 5) and stereotactic radiofrequency abla-tion (n = 11) with local curative intention.The remaining 27 patients underwent palliative treatment for first recurrence.Overall survival of patients who underwent repeated aggres-sive liver-directed therapy was comparable to patients without recurrence (p = 0.938) and was better as compared to patients receiving palliative treatment (p = 0.018).The 5-year overall survival rates for patients without recurrence, the repeated liver-directed treatment group and the palliative treatment group were 54.3%, 47.7% and 12.3%, respectively.By adding stereotactic radiofrequency ablation as an alternative treatment option, the rate of curative re-treatment increased from 11.9% to 37.2%.Conclusion repeated hepatic resection is often precluded due to patient morbidity or anatomical and functional limitations.Due to the application of stereotactic radiofrequency ablation in case of recurrent intrahepatic cholangiocellular carcinoma, the number of patients treated with curative intent can be increased.This leads to favorable clinical outcome as compared to palliative treatment of intrahepatic cholangiocellular carcinoma recurrence.Reported events: 4 patients died not because of tumour progression but from surgical complications, such as therapy-refractory liver abscess in 2 cases, one patient developed a necrosis of the main bile duct and one patient suffered from polf grade c.

Event Description

The complications mentioned in table 2 were related to hepatic resection and not to navigation system.Table 2.Short-term outcome (90days) following hepatic resection.

Manufacturer Narrative

H2) additional information was added to b5 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.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: 18212044
• MDR Text Key: 329041753
• Report Number: 1723170-2023-02410
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• 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: 11/28/2023
• 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): Death
• Patient Age: 63 YR
• Patient Sex: Female