MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 NAVIGATION; INSTRUMENT, STEREOTAXIC

Model Number	9733856R
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
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 system used during an electrode and probe placement procedure.It was reported that an responsive neurostimulation (rns) lead was placed inaccurately.It was reported that they were using a stereotactic frame biopsy procedure.They were placing the rns leads on the left and right side of the patient.They found that the lead was placed inaccurately by looking at the post op scan and saw that the rns lead was in the incorrect place on the left side of the patient.It was superior about 2.5 inches.They checked the coordinates on the system and say that the vertical coordinate was displayed as negative 11, but the surgeon did positive 11 on the frame, which would cause the inaccuracy.They left the rns lead in.No surgery was scheduled to remove the lead at the time.There was no delay to the procedure.It was noted that the patient was impacted.Additional information was received.It was clarified that there was no affect to the patient, just that the leads were placed inaccurately.The leads being placed inaccurately did not have any adverse consequences.It was unknown if a second procedure would be scheduled, but if one is, the local representative would be notified at that time.
Additional Manufacturer Narrative
Ime and imf codes have been added.H2/h3/h6: software analysis determined that no logs or exams were available.There was insufficient information to determine whether a software anomaly contributed to the reported behavior.It was suspected to be user error.Codes b01, c19 and d15 reflect this.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: STEALTHSTATION S7 NAVIGATION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10706339
• Report Number: 1723170-2020-02755
• Device Sequence Number: 3345641
• Product Code: HAW
• UDI-Device Identifier: 00613994603678
• UDI-Public: 00613994603678
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: No Information
• Device Model Number: 9733856R
• Device Catalogue Number: 9733856R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 68