MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INSTRUMENT TRACKER, EM ENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733533

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect em tracker.No parts have been received by manufacturer for analysis.Part not received by manufacturer.

Event Description

A medtronic representative reported that, while in a procedure, their em tracker experienced a recognition failure.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon opted to discontinue the use of the navigation system to continue the procedure to completion.Delay in therapy was less than one hour.There was no impact on patient outcome reported.

Manufacturer Narrative

Additional information: a medtronic representative reported that according to the rep the tracker was able to be recognized after the report event.The site declined to return the device, and the lot number was unobtainable.The doctor refused to provide patient information.

• Brand Name: INSTRUMENT TRACKER, EM ENT
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6177416
• MDR Text Key: 62471666
• Report Number: 1723170-2016-05773
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994353450
• UDI-Public: 00613994353450
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733533
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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