MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC BIOPSY GUIDE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	960-539
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during a cranial biopsy procedure.It was reported that the vertek biopsy precision aiming device would not lock properly.The locking mechanism responsible for gross movements would not lock.A second vertek biopsy set was used to complete the procedure.The procedure was delayed by 5 minutes.There was no impact on patient outcome.

• Brand Name: BIOPSY GUIDE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12274126
• Report Number: 1723170-2021-01993
• Device Sequence Number: 3761549
• Product Code: HAW
• UDI-Device Identifier: 00681490991520
• UDI-Public: 00681490991520
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K954276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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 Model Number: 960-539
• Device Catalogue Number: 960-539
• Device Lot Number: 150303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1