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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hematoma (1884); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 12/29/2022

Event Type  Injury  

Manufacturer Narrative

G2: this event occurred in france, see e1-e3.H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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

Citation: neurosurgery 92:803¿811, 2023 https://doi.Org/10.1227/neu.0000000000002294 summary: background: robot-assisted stereotactic biopsy is evolving: 3-dimensional intraoperative imaging tools and new frameless registratio n systems are spreading.Objective: to investigate the accuracy and effectiveness of a new stereotactic biopsy procedure.Methods: observational, retrospective analysis of consecutive robot-assisted stereotactic biopsies using the neurolocate (renishaw) frameless registration system and intraoperative o-arm (medtronic) performed at a single institution in adults (2019-2021) and comparison with a historical series from the same institution (2006-2016) not using the neurolocate nor the o-arm.Results: in 100 patients (55%men), 6.2 2.5 (1-14) biopsy samples were obtained at 1.7 0.7 (1-3) biopsy sites.An histomolecular diagnosis was obtained in 96% of cases.The mean duration of the procedure was 59.0 ± 22.3 min.The mean distance between the planned and the actual target was 0.7 0.7 mm.On systematic postoperative computed tomography scans, a hemorrhage =10 mm was observed in 8 cases (8%) while pneumocephalus was distant from the biopsy site in 76%.A karnofsky performance status score decrease =20 points postoperatively was observed in 4%.The average dose length product was 159.7 63.4mgy cm.Compared with the historical neurosurgical procedure, this new procedure had similar diagnostic yield (96 vs 98.7%; p =.111) and rate of postoperative disability (4.0 vs 4.2%, p =.914) but was shorter (57.8 22.9 vs 77.8 20.9 min; p.001) despite older patients.Conclusion: robot-assisted stereotactic biopsy using the neurolocate frameless registration system and intraoperative o-arm is a safe and effective neurosurgical procedure.The accuracy of this robot-assisted surgery supports its effectiveness for daily use in stereotactic neurosurgery.Reported events: this was a retrospective study, with 55 male patients and 45 females patients.The mean age of the patients was 64.5 years.Postoperatively, 6 patients experienced disability, 7 patients experienced neurological deficit, 2 patients experienced epileptic seizures, and 1 patient experienced hematoma requiring surgical evacuation.

• 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: 18469156
• MDR Text Key: 332374903
• Report Number: 3004785967-2024-00017
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2024

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?: 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: Not provided
• Initial Date FDA Received: 01/08/2024
• 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): Hospitalization; Required Intervention; Life Threatening; Disability
• Patient Age: 65 YR
• Patient Sex: Male