MAUDE Adverse Event Report: NAVINETICS NAVINETICS REUSABLE STEREOTACTIC SYSTEM; Neurological stereotaxic Instrument

Model Number	NN1000
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative became aware of dbs lead implantation procedure using the navinetics stereotactic system where one of the two implanted leads was reported over 2mm from the planned target, the other lead was accurately positioned under 2mm.The user stated overall positive clinical outcomes and no intention to readjust the lead placement, and no reported adverse effects experienced by the patient.
Additional Manufacturer Narrative
Review of imaging data with the user did not identify a clear root cause for the observed target inaccuracy.The user did speculate that there may have been influence from either or both the dura during cannula implantation and fixation of the ao drive on the frame which could be a factor in the observed lead deviation.Accurate implantation of the second lead in this patient indicates no apparent product malfunction.Navinetics is submitting this report to comply with 21 cfr part 803, medical device reporting.Submission of this report does not constitute an admission of product problem, malfunction or product defect.

• Brand Name: NAVINETICS REUSABLE STEREOTACTIC SYSTEM
• Common Device Name: Neurological stereotaxic Instrument
• Manufacturer (Section D): NAVINETICS; 206 south broadway; suite 700; rochester MN 55904
• Manufacturer (Section G): NAVINETICS; 206 south broadway; suite 700; rochester MN 55904
• Manufacturer Contact: danielle jondal ; 206 south broadway; suite 700; rocheser, MN 55904 ; 5073613570
• MDR Report Key: 18580727
• Report Number: 3023194190-2024-70002
• Device Sequence Number: 12812739
• Product Code: HAW
• UDI-Device Identifier: 10850023620078
• UDI-Public: 10850023620078
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K231392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2024

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: NN1000
• Device Catalogue Number: NN1000
• Device Lot Number: 331806122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALPHA OMEGA MICRODRIVE & CANNULAS, DBS LEADS
• Patient Sex: Prefer Not To Disclose