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

Model Number S7 PLANNING STATION

Device Problem Device Emits Odor (1425)

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

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

Patient weight not available from the site.It was later reported that the planning station was in the operating room due to it being used to calculate a stereotactic trajectory.No parts have been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that as the system was being tested prior to an electrode and probe placement case, an odor was reported coming from the screen.The site used an external screen to continue the case.There was no patient impact or delay in surgery reported.Surgery proceeded as planned.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The monitor was replaced.The navigation system then passed the system checkout and was found to be fully functional.Part not received by manufacturer for analysis.

• Brand Name: STEALTHSTATION S7 PLANNING STATION
• 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: oksana ditolla ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 717447330
• MDR Report Key: 6594062
• MDR Text Key: 76057294
• Report Number: 1723170-2017-02205
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994532398
• UDI-Public: 00613994532398
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7 PLANNING STATION
• Device Catalogue Number: 9734048
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2015
• 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: 47 YR