MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PATIENT TRACKER 9734887XOM NON-INVASIVE; INSTRUMENT, STEREOTAXIC

Model Number 9734887XOM

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

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 device being used intra/peri-operatively of a functional endoscopic sinus surgery (fess) procedure.It was reported that the non-invasive patient tracker (nipt) was not initializing.The site unplugged the tracker and tried plugging it back.It is unknown if there is a delay in the procedure and no impact on patient outcome.Additional information noted that the cause was a faulty/misfunctioning patient tracker.They discarded the one that was not working and the new one worked as expected.Also, there was no delay in procedure.

• Brand Name: PATIENT TRACKER 9734887XOM NON-INVASIVE
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: 11084577
• MDR Text Key: 226795141
• Report Number: 1723170-2020-03417
• Device Sequence Number: 1
• Product Code: HAW
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734887XOM
• Device Catalogue Number: 9734887XOM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 121