MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) LINEAR BLUNT PROBE HC; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733879
Medical Device Problem Codes	Device Stops Intermittently (1599); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations.A medtronic representative went to the site to test the equipment.The representative reported that the issue could be isolated to the suspect instrument.The suspect instrument has not been received by the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that, while in a cranial resection, the round tip active probe was intermittently being recognized when used alongside the reference frame.Disconnecting the reference frame and reconnecting it did not restore functionality.The navigation system was restarted and functionality was restored.The reported issue then reoccurred again and the navigation system was restarted again to restore functionality.The procedure was then completed with the navigation system.

• Brand Name: LINEAR BLUNT PROBE HC
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6972815
• Report Number: 1723170-2017-04300
• Device Sequence Number: 498384
• Product Code: HAW
• UDI-Device Identifier: 00763000053529
• UDI-Public: 00763000053529
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

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
• Operator of Device: Physician
• Device Catalogue Number: 9733879
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1