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

Model Number BI-700-00027-120

Device Problems Loose or Intermittent Connection (1371); Unintended Collision (1429); Device Displays Incorrect Message (2591); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

Return requested.Replacement mvs interface kit shipped to site 11/18/2015.No parts have been received by manufacturer for analysis.Issue resolution: imaging system was not connecting to mvs.Checked light on mvs computer and received intermittent connection with umbilical manipulation.Replaced umbilical.Issue resolved.Performed system check-out.Unit operates as expected.On 1/19/2015 a medtronic representative performed an imaging system check-out, all areas passed.System performed as intended.

Event Description

A medtronic representative reported that, while in a spine fusion procedure, they took a successful first spin.The site technician then bumped the reference frame which meant they set-up for a new spin and suddenly the pendant displayed a message "connected not ready." for mobile viewing system (mvs) communication.In trouble-shooting, the medtronic representative re-booted both image acquisition system (ias) and mobile viewing system (mvs) several times and re-seated umbilical cable multiple times with no change.The remote desktop was not able to be accessed.The surgeon opted to discontinue the use of the navigation system and the imaging system to proceed with the surgery to completion.The surgeon placed screws free-hand.Delay in therapy was 25 minutes.There was no impact on patient outcome.

Manufacturer Narrative

Medtronic investigation of returned suspect device confirmed the reported event.Continuity testing of the mvs interface (umbilical) cable found the cable fails from the lemo connector pins 4 & 5.The lemo pins are open to 3 position mte (black) connector pins 2 & 3.The reported event was confirmed to be caused by an electrical failure mode.As previously reported the cable was replaced on-site to resolve the issue.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5300661
• MDR Text Key: 34261810
• Report Number: 1723170-2015-01558
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2006
• 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
• Patient Age: 49 YR
• Patient Weight: 52