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

Model Number BI70000028230

Device Problems Imprecision (1307); Wireless Communication Problem (3283)

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

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.The manufacturer representative went to the site to test the imaging system.After the trackers were re-calibrated on both sides the navigation accuracy passed.A system functionality test was performed.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while in a cervical spinal fusion, the user reported an imprecision of 2-3 millimeters.It was reported that the imaging system trackers were in need of recalibration.There was no reported impact on patient outcome.Additional information was received stating that the procedure was completed by compensating for the inaccuracy.There was no delay to the procedure.There were no adverse event observed with the patient.

• Brand Name: OARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 10157268
• MDR Text Key: 195249928
• Report Number: 3004785967-2020-00687
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2020

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: No Information
• Device Model Number: BI70000028230
• Device Catalogue Number: BI70000028230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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