MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problems Use of Device Problem (1670); Noise, Audible (3273); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: (b)(4).A medtronic representative went to the site to test the equipment.Testing revealed that the system was found to beeping and wouldn't fully boot upon arrival.While troubleshooting the generator was found to be out of specification.The generator control battery was replaced and rtc was reset.The unit fully booted and was able to take complete a spin and scout.The imaging system then passed the system checkout and was found to be fully functional.B01, c02, d02 are applicable.H6: multiple fdd/annex a codes were reported.A0508 was coded for the image acquisition system (ias) beeping.(b)(6) was coded for the system stuck in initialization.A23 was coded for the system returning to error state after reboots.Additional codes: multiple imf/annex f codes were reported.F12 was coded for the surgery aborted post-incision.F1908 was coded for the surgical delay of less than one hour.(b)(4) was coded for the surgery aborted.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

Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that the imaging system did not pass the initialization screen.The image acquisition system (ias) was beeping continuously as well.They site tried to reboot the system three times before the call, but the system kept returning to the same error-state.The surgery was aborted since the surgeon didn't believe optimal results could be achieved without the imaging system.Medtronic imaging and navigation were aborted as well.  the site tried to reboot the system without the umbilical cord connected, but that did not resolve the issue.This occurred intraoperatively, and there was a surgical delay of less than one hour.There was no reported impact to patient outcome.Additional information was received.The surgery was aborted post-incision and anesthesia.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: 18876602
• MDR Text Key: 337344738
• Report Number: 3004785967-2024-00155
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 139 KG