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

Model Number S7

Device Problem No Device Output (1435)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The suspect part 24v battery was returned to the manufacturer for evaluation.However, results are not available at this time.

Event Description

Medtronic received information that, while outside of a procedure, the navigation system would power down after being unplugged from the outlet.It was noted the battery was not able to hold a charge.There was no patient present when this issue was identified.

Manufacturer Narrative

The analysis on the battery was completed by medtronic personnel.Testing found that the battery would not pass load testing.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

A medtronic representative went to the site to test the equipment.Testing revealed that after replacing the battery the system functioned as intended.The system then passed the system checkout and was found to be fully functional.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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7567686
• MDR Text Key: 110035287
• Report Number: 1723170-2018-02470
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• 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: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2013
• 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