MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-06 for STEALTHSTATION S8 EM ENT SYSTEM 9735669 manufactured by Medtronic Navigation, Inc.
[183568490]
Other relevant device(s) are: product id: 9735736, software version: 1. 2. 0. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183568491]
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess). It was reported that the site was unable to load an exam. The site had attempted two other discs before calling technical services (ts). It was reported that the system would state it was attempting to read the digital intercommunication of medicine (dicom) but then the message would go away and nothing would happen. The site checked a non-medtronic dicom solution to see if the exam would load that way but that did not resolve the issue. A manufacturer representative logged into the admin and opened up the disc which showed the director file and exam contents. The exam contents were moved into a folder on the desktop to attempt to load through the file system, but the issue remained. The procedure was completed without the use of the navigation system and there was no reported impact to patient outcome. There was a reported delay to the procedure of less than one hour due to this issue. It was noted that the same exam loaded without issue onto a different navigation system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00784 |
| MDR Report Key | 9802192 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2016-10-07 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEALTHSTATION S8 EM ENT SYSTEM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | PGW |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 9735669 |
| Catalog Number | 9735669 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |