MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BIOPSY NEEDLE KIT, PASSIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733068
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number unavailable as the suspect biopsy needle was discarded at the site.Device manufacturing date is dependent on lot number, therefore, unavailable.On (b)(6) 2017 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.This part was discarded by the site and will not be returned to manufacturer for analysis.
Event or Problem Description
A medtronic representative reported that, while in a cranial biopsy procedure, after the trajectory was locked, the biopsy needle would not track.This happened twice.The medtronic representative was confident the camera could see both spheres on the camera.The surgeon opted to discontinue navigating the biopsy needle, however, still used it to extract a sample.No further details regarding the behavior, or specifically when it occurred, were provided.The surgeon completed the procedure without the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

• Brand Name: BIOPSY NEEDLE KIT, PASSIVE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6358865
• Report Number: 1723170-2017-00767
• Device Sequence Number: 19226701
• Product Code: HAW
• UDI-Device Identifier: 00643169546820
• UDI-Public: 00643169546820
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/24/2017

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: 9733068
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2017
• Initial Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 68