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 Problems Loss of Range of Motion (2032); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 05/05/2021

Event Type  malfunction  

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 accepted 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

Efrima, b., ovadia, j., drukman, i., khoury, a., rath, e., dadia, s., gortzak, y., albagli, a., sternheim, a., segal, o.Cryo-surgery for symptomatic extra-abdominal desmoids.A proof of concept study.Journal of surgical oncology.2021.124 (627-634) https://doi.Org/10.1002/jso.26528 abstract background and objective extra abdominal desmoid tumors are rare, highly aggressive, and invasive benign soft tissue tumors.Current treatment modalities show high levels of recurrence and comorbidities.Cryo-surgery as an alternative was subsequently investigated.Methods in this retrospective, single center study 11 patients showing symptomatic tumors were treated with individualized cryo-surgery.Tre atment protocol included preoperative planning using computer rendered 3d models, intraoperative navigation and execution using cone beam guidance, and postoperative magnetic resonance imaging image analysis using a gaussian mixture model software.Subjective outcomes were reported using short form health survey (sf-36) questionnaires.Results sixteen ablations were performed, each demonstrating a complete match with the determined preoperative plan and model.A total of 9/11 (82%) of patients showed improvements in symptoms and a reduction in tumor volume while 2/11 (18%) did not.Average reduction in tumor volume and viable segments were 36.7% (p=0.0397) and 63.3% (p=0.0477), respectively.Mild complications according to the sir adverse event classification guidelines were experienced in 3/16 (19%) ablations.Sf-36 scores showed a statistically significant improvement (p=0.0194) in the mental health category and a nonsignificant (p=0.8071) improvement in the physical health category.Conclusion cryo-surgery using the three-phase protocol as described may improve the overall outcome of future ablation procedures.Reportable events: one patient developed mild frostbite of the overlying skin of the shoulder with no functional damage one patient experienced a limitation in range of motion of the hip following the procedure that had resolved by the 6-month follow-up.One patient developed swelling in the axilla and arm immediately after treatment and it cleared by the 6-month follow-up see attached literature article.

• 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: 16867095
• MDR Text Key: 314893403
• Report Number: 3004785967-2023-00274
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/11/2023
• Initial Date FDA Received: 05/04/2023
• 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 Age: 35 YR
• Patient Sex: Female