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

Model Number S7

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.A medtronic representative went to the site and reseated the memory card of the computer.After reseating the memory card, the equipment run successfully.Issue resolved.

Event Description

A surgeon reported the monitor of the s7 stealthstation was flashing when the system booted up.This was during setup, prior to the patient being present.

• 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: catherine eaton ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 6699666
• MDR Text Key: 79641304
• Report Number: 1723170-2017-02837
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169505742
• UDI-Public: 00643169505742
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• 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