MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number	BI70000028120
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: no parts have been received by the manufacturer for evaluation.This regulatory report is being submitted due to a retrospective review through capa 624932.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that the system would not take a 2d or 3d scan.The site rebooted the unit and after reboots, they were able to scan, but it was reported that this resulted in "a big delay to the case." there was no reported impact to the patient.
Additional Manufacturer Narrative
The initial regulatory report was submitted due to retrospective review through capa 624392, not the previously listed 624932.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.

• Brand Name: O-ARM 1000 IMAGING SYSTEM 3RD EDITION
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20675508
• Report Number: 3004785967-2024-00670
• Device Sequence Number: 21068094
• Product Code: OXO
• UDI-Device Identifier: 00643169353428
• UDI-Public: 00643169353428
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K092564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: BI70000028120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown