MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC BIOPSY NEEDLE KIT; INSTRUMENT, STEREOTAXIC

Model Number	9733068
Medical Device Problem Codes	Imprecision (1307); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
Medtronic received information regarding a navigation device being used during a cranial biopsy.It was reported that the cranial biopsy needle was not recognized by the navigation system.It was reported that a second biopsy needle was opened without resolution.Depth of the biopsy could not be measured by the navigation system due to the reportedissue.Manual measurement was conducted and the biopsy proceeded with collection of a diagnostic sample.There was no reported impact on patient outcome.

• Brand Name: BIOPSY NEEDLE KIT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11574321
• Report Number: 1723170-2021-00797
• Device Sequence Number: 3521400
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066526520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1