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

Model Number	9733068
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.The instrument was discarded, so no analysis was performed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a cranial biopsy procedure.The issue occurred post incision, after anesthesia had been administered and caused delay to the surgery.It was reported that the system did not track the location of the passive biopsy needle; thus it was not possible to navigate it.The issue was resolved by replacing the passive biopsy needle with a new one.The surgery was completed with navigation.There was no reported impact on patient outcome.

• Brand Name: BIOPSY NEEDLE KIT, PASSIVE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8562570
• Report Number: 1723170-2019-02036
• Device Sequence Number: 14026928
• Product Code: HAW
• UDI-Device Identifier: 00643169546820
• UDI-Public: 00643169546820
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 10/24/2019
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066529717A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1