MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problem Swelling (2091)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that during the navigate task of a catheter placement procedure there was an alleged inaccuracy.The clinical specialist (cs) called in and said the site had a successful registration, 1.9mm registration metric.When verifying registration, the surgeon just checked the tip of the nose and fiducials and said he was accurate.The computed tomography (ct) was done day of the procedure.The surgeon set a plan and target, the resident used the stylet and got no cerebrospinal fluid (csf).The surgeon did a pass and did not get any csf either.He then abandoned navigation.The patient had swelling on the side of his head and the head-holder was in the registration model as well.No post-op scans were taken.The cs stated that he used a green demo head for testing and both registration and navigation were perfect.There was a delay to the procedure of less than one hour.Manufacturer representative (rep) indicated that the amount of inaccuracy was unknown to both the rep and the surgeon.After the in accuracy was discovered navigation was aborted and the shunt was successfully placed.The swelling on the head was a symptom pre-existing the procedure.Additionally, the rep indicated that registration had a metric of 1.0 and the patient had a large hematoma on the right side.The rep was advised to remove the head holder and avoid using auto refine after modifying the 3d model.The rep then reported that the patient tracker was placed on the arm of the mayfield and the patient was pinned therefore the patient tracker would have been roughly 6 inches from the forehead of the patient.The navigated crosshairs were seen in the ventricle each pass.Later and healthcare provider (hcp) mentioned they had placed the patient tracker on the forehead and that they checked the integrity of the tracker after navigation was aborted and it appeared to be in the same position.The patient has been doing okay since surgery.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that the issue could not be confirmed or replicated, no components were replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Date mfr rec updated to the correct date if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Other relevant device(s) are: product id: 9735737, software version: 1.2.0.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the case was very complicated.

Manufacturer Narrative

A software investigation was initiated in which patient archives and software logs were reviewed.Massive hematoma on patient right.Properly avoided during registration.12 fiducials placed, 11 auto-detected.User touched a physical fiducial that did not have a corresponding image point.Unable to assess navigation accuracy.There was insufficient information to determine root cause of the reported behavior.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 PREMIUM SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8564270
• MDR Text Key: 143568565
• Report Number: 1723170-2019-02040
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/05/2019

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
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 04/30/2019; 04/30/2019; 07/12/2019; 09/04/2019
• Supplement Dates FDA Received: 05/08/2019; 05/08/2019; 07/18/2019; 09/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 113