MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PATIENT TRACKER 9734887 NON-INVASIVE; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9734887

Device Problem Imprecision (1307)

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

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a navigation system that was used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the patient was easily registered with an error of 1.3, and when they checked the registration immediately after the anatomical landmarks lined up nicely.The interference number on the patient tracker was 0.4, and instruments were easily verified and tacked smoothly.When the straight suction was introduced into the procedure, the surgeon reported that if appeared to be about 1cm off.Tried another straight suction with the same result.Accuracy was also off with a straight probe.The patient was re-registered and inaccuracy resolved.There was a reported delay of less than one hour.There is no known impact on patient outcome.

• Brand Name: PATIENT TRACKER 9734887 NON-INVASIVE
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10240013
• MDR Text Key: 198412358
• Report Number: 1723170-2020-01847
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734887
• Device Catalogue Number: 9734887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR