MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	S7
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned to the manufacturer for analysis.A medtronic representative went to the site to test the equipment.Testing revealed that the system functioned as intended.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a transforaminal lumbar inter-body fusion (tilf).It was reported that when the site navigated on the imaging system, navigation was 2mm off the skin in the sagittal view.This event occurred intra/perioperatively with less than one hour delay to surgical time.There was no impact on patient outcome.
Additional Manufacturer Narrative
Correction: unique device identification (udi), device manufacture date updated to proper value.
Additional Manufacturer Narrative
There was no injury associated with the inaccuracy.The issue was resolved by the healthcare provider adjusting the inaccuracy and also adjusting the frame movement from placement close to the skin.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7597787
• Report Number: 1723170-2018-02756
• Device Sequence Number: 1133867
• Product Code: HAW
• UDI-Device Identifier: 00613994724014
• UDI-Public: 00613994724014
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2019

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: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 06/26/2018; 06/26/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 06/29/2018; 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 90