MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MAIN CART 9735669 STEALTH S8 EM ENT INSTRUMENT, STEREOTAXIC

Model Number 9735669

Device Problems Computer Software Problem (1112); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern. Concomitant medical product: sfw kit 9735736, stealth s8 ent. The software investigation found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software tracking database. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside of procedure, with no patient present. It was reported that while the site attempted to archive a patient, the received transfer failed. A manufacturer representative (rep) found that there was an exam tied to the patient with 0 slices. After deleting the extra exam, the issue was resolved and the site was able to export.

• Brand Name: MAIN CART 9735669 STEALTH S8 EM ENT
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8661614
• MDR Text Key: 146813786
• Report Number: 1723170-2019-02860
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse