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

Model Number BI70002000

Device Problems Device Damaged Prior to Use (2284); Noise, Audible (3273); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: information references the main component of the system.Other relevant device(s) are: product id: kit svc o2 bi71000450 power supply psi, lot: unknown product id: kit svc o2 bi71000576 starter upgd kit, lot: unknown 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 spinal procedure.It was reported that the site was getting ready to do a spin and right before the 3d spin, the system was beeping and would not do a 3d spin.The ias (image acquisition system) was rebooted but was still beeping.A second reboot was done and the system then got stuck at the initializing radiation status bar.A 3rd reboot was done, scout shots were redone, but right after the ap (anteroposterior) image, the system started beeping.  a lateral image was attempted but the system would not take the image.Use of navigation and imaging was aborted, but the case was completed.The procedure was delayed by 20 minutes and there was no impact on patient outcome.

Manufacturer Narrative

H3: the power supply was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed with the returned power supply.However, it failed bench testing due to a drifting voltage.It had an electrical failure.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.

Manufacturer Narrative

Concomitant medical product: section d information references the main component of the system.Other relevant device(s) are: product id: kit svc o2 bi71000450 power supply psi , lot/serial: rev.1 : s/n (b)(6) product id: kit svc o2 bi71000576 starter upgd kit, lot/serial: rev.2 : s/n (b)(6) product id: kit svc bi71000226 pcba generator startr, lot/serial: rev.1 : s/n (b)(6) fdm b21, fdr c21, and fdc d16 are applicable to the concomitant products.H3, h6: a medtronic representative went to the site to perform a system checkout.The power supply and starter board were replaced.The starter board upgrade kit was found to have an out of box failure.The j27 cables were found to be mislabeled, cables 1 and 2 were swapped and the issue resolved.Fdm b01, fdr c02, fdc d02 are applicable to the system checkout 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.

Manufacturer Narrative

The starter board was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed; no failure was found with the board.The pcba board was returned to the manufacturer for analysis.Analysis found that the reported issue could be confirmed; a component was broken off and missing.Analysis found that the reported event was related to a mechanical issue.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.

• 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
• MDR Report Key: 11629771
• MDR Text Key: 262414455
• Report Number: 3004785967-2021-00448
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• Combination Product (y/n): N
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR