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

Model Number S7

Device Problems Erratic or Intermittent Display (1182); Loose or Intermittent Connection (1371)

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

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.Testing revealed that the camera doesn't track the instruments all the time.The communication was lost between camera and tools after a while of turning on the system.The positioning sensor unit (psu), the stand-alone control unit (scu) and principal component analysis (pca) were all refurbished.The hardware, software, and instruments passed the system checkout.The imaging system then passed the system checkout and was found to be fully functional.No parts have been returned to the manufacturer for evaluation.Udi and manufacture date not available for this system at time of filing.

Event Description

Medtronic received information regarding a navigation device being used for a cranial resection procedure.The issue occurred intraoperatively during the navigate task and caused no delay to the surgery.It was reported that the camera stopped tracking instruments.The register task could be done without problems, but when the site wanted to navigate, after some hours, the camera did not see the instruments.The spheres were changed, nothing was on the sight view, but the issue was not resolved.The surgery was completed without navigation and there was no impact on patient outcome.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.

Manufacturer Narrative

The scu was returned to the manufacturer for analysis.Analysis found that the scu was fully functional when connected to a known good system.A check of the logs did not reveal any issue.No fault found.The psu was returned to the manufacturer for analysis.Analysis found that the returned psu powered up without amber fault light on but check of the event log revealed a intermittent history of sensor voltage high faults.Psu passed accuracy test.Analysis found that the reported event was related to a electrical issue.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.The i/o hub was returned to the manufacturer for analysis.Analysis found that the i/o hub was found fully functional having passed functional test.No fault found.

Manufacturer Narrative

Additional investigation found that the issue was verified to be isolated to a shorted component located on the main board of the positioning sensor unit (psu).If information is provided in the future, a supplemental report will be issued.

• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7682646
• MDR Text Key: 113876080
• Report Number: 1723170-2018-03355
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• 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: 9733858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2010
• 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