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

Model Number BI70002000

Device Problems Data Problem (3196); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer representative went to the site to test the imaging system.The reported issue was confirmed and parts were replaced.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.(b)(4).No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system.It was reported outside of a procedure that there was some issue on imaging system when the manufacturer representative went to the site to visit for the navigation checkup.There was possibly a connection issue to can bus connectivity.This was seen in the imaging system error logs.No patient was present at the time of the event.Update from the manufacturer representative stating that the site was not able to move the imaging system.After the system was rebooted everything was working correctly.They also stated that "can bus" is a communication protocol.

Manufacturer Narrative

The cable assay was returned to the manufacture for evaluation.After functional testing, performance testing and visual/physical examination the reported issue was not confirmed.The mobile view station (mvs) interface cable passed bench testing.The cable passed continuity and gbit test.Passed visual inspection.It was installed into a known working system motion and generator readied.Charging and communication were successful.Perform multiple 2d and 3d images, all were successful.No fault found.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: 9139650
• MDR Text Key: 169335435
• Report Number: 3004785967-2019-01704
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 11/21/2019
• Supplement Dates FDA Received: 10/21/2019; 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1