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

Model Number BI70002000

Device Problems Positioning Problem (3009); Unintended Movement (3026); Noise, Audible (3273); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system used during a sacroiliac and thoracolumbar procedure.It was reported that there were issues moving the system.It was stated that it was difficult to move the system and once it was in the room, the system continued to roll slightly after it was parked.While taking ap and lateral images, the system made an odd sound.The 3d image was taken and a message appeared stating the spin was terminated early but the exam did show up.There was no delay to the procedure and no impact to the patient.

Manufacturer Narrative

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

2020-jun-11 it was reported that movement was because the clutch was disengaged and the odd noise was because of a magnet was half off the cable chain track.It was stated that the exam did show up, even though there was a message stating that the spin was terminated early and the spin was still able to be used.

Manufacturer Narrative

H2, h3, h6: a medtronic representative visited the site to evaluate the equipment.It was found that the clutch was disengaged.The rep re-engaged the clutch and drove the system around with no issues.It was found that two cable chain magnets were half off.The rep fixed the magnets to the cable chain.At this point, the unit was operational.Codes 10, 114, and 4307 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.

• Brand Name: O2
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 10114598
• MDR Text Key: 195520589
• Report Number: 3004785967-2020-00626
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• Combination Product (y/n): N
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2020

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
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 06/03/2020; 06/11/2020
• Supplement Dates FDA Received: 06/11/2020; 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1