MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number UNK_OARM_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/03/2023

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

Levy, a.S., merenzon, m.A., eatz, t., morell, a.A., eichberg, d.G.Bloom, m.J., shah, a.H., komotar, r.J., ivan, m.E.Development of an enhanced recovery after laser ablation surgery protocol: a preliminary analysis.Neuro-oncology practice.2023.10(3), 281¿290.Https://doi.Org/10.1093/nop/npad007.Background.Enhanced recovery after surgery (eras) programs are a model of care that aim to improve patient outcomes, reduce complications, and facilitate recovery while reducing healthcare-associated costs and admission length.While such programs have been developed in other surgical subspecialties, there have yet to be guidelines published specifically for laser interstitial thermal therapy (litt).Here we describe the first multidisciplinary eras preliminary protocol for litt for the treatment of brain tumors.Methods.Between the years 2013 and 2021, 184 adult patients consecutively treated with litt at our single institution were retrospe ctively analyzed.During this time, a series of pre, intra, and postoperative adjustments were made to the admission course and surgical/anesthesia workflow with the goal of improving recovery and admission length.Results.The mean age at surgery was 60.7 years with a median preoperative karnofsky performance score of 90 ± 13.Lesions were most commonly metastases (50%) and high-grade gliomas (37%).The mean length of stay was 2.4 days, with the average patient being discharged 1.2 days after surgery.There was an overall readmission rate of 8.7% with a litt-specific readmission rate of 2.2%.Three of 184 patients required repeat intervention in the perioperative period, and there was one perioperative mortality.Conclusions.This preliminary study shows the proposed litt eras protocol to be a safe means of discharging patients on postoperative day 1 while preserving outcomes.Although future prospective work is needed to validate this protocol, results show the eras approach to be promising for litt.Reported events: the second patient underwent external ventricular drain placement for management of intraventricular hemorrhage (ich) 4 days after litt.This patient¿s condition rapidly declined, and she expired on day 6 of readmission, representing the only perioperative mortality in this cohort.

• Brand Name: O-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18030091
• MDR Text Key: 326857344
• Report Number: 3004785967-2023-00663
• Device Sequence Number: 1
• Product Code: OXO
• 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: 10/30/2023

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_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/30/2023
• 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: 61 YR
• Patient Sex: Female