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

Model Number S7

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to site to test the equipment.Representative reported that the system was functioning and was unable to replicate the reported issue.Positioning sensor unit (psu) was replaced as a preventive action.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The positioning sensor unit (psu) has not been received by the manufacturer for evaluation.

Event Description

A site representative reported that during cranial resection, after a while the positioning sensor unit (psu) of the navigation system did not track instruments properly after a successful registration.No noise or beeps were noticed from the camera by site.The procedure was completed without the use of navigation.There was no delay to procedure.No impact on patient outcome.

Manufacturer Narrative

Correction: product, unique device identification (udi) and associated fields updated to proper value.

Manufacturer Narrative

The positioning sensor unit (psu) was returned to the manufacturer for analysis.Analysis found that when connected to a known good system, the positioning sensor unit (psu) powered up without the amber fault light on.A check of the event log did not reveal any adverse events.Positioning sensor unit (psu) failed 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.

Manufacturer Narrative

Correction: product and related fields updated to proper value.

• 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 ; 7208902515
• MDR Report Key: 7341469
• MDR Text Key: 102481299
• Report Number: 1723170-2018-01141
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2009
• 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