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 Cerebrospinal Fluid Leakage (1772); Muscle Weakness (1967); Nerve Damage (1979); Insufficient Information (4580)

Event Date 12/10/2022

Event Type  Injury  

Manufacturer Narrative

This event occurred in japan.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: https://doi.Org/10.1016/j.Jos.2022.10.026 summary: background: there is little information on outcomes for spinal cord tumor treated surgically with instrumentation.Analysis of surgical outcomes and complications in such cases is needed to develop generalizable conclusions and to help inform patients.Methods: the subjects were 41 patients treated with instrumentation surgery for dumbbell type tumor resection.Demographic data; tumor histology, level, and location; number of fused vertebra; use of a bilateral or hemilateral screw; operative time; ebl; tcmep monitoring; lumbar subarachnoid drainage; duration of subfascial drainage; postoperative motor and sensory deficits; csf leakage, implant-related complications; time for union of fused vertebra; salvage surgeries, and pre-/postoperative mccormick scale were obtained from medical records.Significant factors related to postoperative motor deficits were identified.Results: postoperative motor deficit occurred in 9 cases (22.0%) and all recovered in 30 days after surgery.Csf leakage at 7 days and 2 years after surgery was subfascial (n ¼ 31, n ¼ 6) and subcutaneous (n ¼ 3, n ¼ 4).Cases with postoperative motor deficits more commonly had lower cervical lesions; those with csf leakage had longer operative times; and those with delayed union had more use of hemilateral instrumentation.Conclusion: in this study in 41 spinal cord tumors treated surgically with instrumentation, the rate of postoperative motor deterioration was 22.0%, and csf leakage was found in 17.1%.Reported event(s): this article documents the procedures for 41 patients that presented with cervical or lumbar tumors.21 of the patients were male and 20 were female, with a mean age of 46.8 years.Postoperative motor deficit occurred in 9 cases, and all recovered in 30 days after surgery.The motor deficits included c5 palsy (n ¼ 3), c6 palsy (n ¼ 1), c7 palsy (n ¼ 2), c8 palsy (n ¼ 1), l4 palsy (n ¼ 1), and muscle weakness in the distal lower extremities originating in the conus medullaris.Subfascial and subcutaneous cerebrospinal fluid (csf) leakage was found in 31 and 6 cases at 7 days after surgery, and in 3 and 4 cases at 2-year follow-up.Implant-related complications occurred in 1 cases (adjacent disease).

Manufacturer Narrative

H2) additional information was added to b5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received stating that the site has confirmed, there was nothing related to this adverse event report in navigation.None of the adverse events mentioned in the article were related to the medtronic device.

• 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: 18640537
• MDR Text Key: 334548351
• Report Number: 3004785967-2024-00081
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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: 02/01/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/26/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male