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

Model Number S7

Device Problems Erratic or Intermittent Display (1182); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Unique device identification (udi) is unavailable.Device serial number is unavailable.Device manufacturing date is dependent on serial number, and is therefore, unavailable.No parts have been received by the manufacturer for evaluation.Part not returned.

Event Description

A site representative reported that, while in a procedure, it was identified that the navigation system was having intermittent unusual behavior, described as "extreme jitter." when using the synergy cranial guidance view at high image zoom levels.There was no known impact on patient outcome.No additional information was provided.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that they could replicate the reported issue.

Manufacturer Narrative

The reported issue was reviewed by medtronic personnel.The review found that the software functioned as designed.

Manufacturer Narrative

Patient weight field not sufficient to hold all digits, should read: (b)(6).Patient demographic information and event description.

Event Description

Medtronic received information regarding a navigation device being used intra-operatively for an electrode and probe placement procedure.It was reported that there was an unusual behavior (described as an extreme "jitter") on the synergy cranial 3.0.X guidance view at high image zoom levels.Video footage was provided by the health care professional illustrating/describing the issue as the "jumping bean" occurring on the navigation screen.It was further reported that: the issue was able to be replicated on-site with a phantom; and that at very high zoom levels, there may be some small jitter tracking the tool--this is expected and the system is functioning as designed.There was a reported delay to the procedure of approximately 5 minutes due to the issue, and no known impact on the patient outcome.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7315555
• MDR Text Key: 101625397
• Report Number: 1723170-2018-00810
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/20/2018

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: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 03/23/2018; 05/15/2018; 09/13/2018; 09/18/2018
• Supplement Dates FDA Received: 04/04/2018; 06/11/2018; 09/13/2018; 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR
• Patient Weight: 88