MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number 9732719

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

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 10/05/2023

Event Type  Injury  

Event Description

Giordano, m., innocenti, n., rizzi, m., rinaldo, s., nazzi, v., eleopra, r., levi, v.Incidence and management of idiopathic peri-lead edema (iple) following deep brain stimulation (dbs) surgery: case series and review of the literature.Clinical neurology and neurosurgery.2023.234 (108009) https://doi.Org/10.1016/j.Clineuro.2023.108009 objective: idiopathic peri-lead edema (iple) is being increasingly described as a potential complication occurring after dbs surgery.Its incidence and relationship to post-operative symptoms, though, are still poorly defined and its understanding and management yet limited.Methods: we reviewed delayed (= 72 h) post-operative ct imaging of patients who underwent dbs surgery at our institution.A comparison of clinical and laboratory findings was carried out between patients with iple and controls.Results: 61 patients, accounting for 115 electrodes, were included.Incidence of iple was 37.7 % per patient and 29.5 % per electrode.Patients with iple were significantly older than controls (52.82 ± 15.65 years vs 44.73 ± 18.82 years, p = 0.04).There was no difference in incidence of new-onset neurological symptoms between patients with iple and controls.Longer operative time (180.65 ± 34.30 min vs 158.34 ± 49.28 min, p = 0.06) and a greater number of mers per electrode were associated with iple (3.37 ± 1.21 vs 3.00 ± 1.63, p = 0.089), though these comparisons did not meet the statistical significance.None of the patients with iple underwent hardware removal, with iple vanishing spontaneously over months.Conclusions: iple is an underestimated, benign event that may occur after dbs surgery.Age, longer operative time and mer use may represent risk factors for iple formation, but further studies are needed.The presence of post-operative neurological symptoms and fever was not associated with iple presence, highlighting its benign nature and suggesting that empiric treatment may not be always justified.Reported events: two patients with iple (8.69 % of the iple cohort) presented new- onset neurological symptoms after surgery and underwent corticoste-roid therapy see attached literature article.

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.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.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: O-ARM 1000 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: 18131575
• MDR Text Key: 328108191
• Report Number: 3004785967-2023-00694
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050996
• 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: 11/14/2023

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: 9732719
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/14/2023
• 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): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male