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 2020-03-30 for S8 PREMIUM STEALTHSTATION NAVIGATION SYSTEM 9735665 manufactured by Medtronic Navigation, Inc.
[186590770]
A medtronic representative went to the site to test the equipment. Testing revealed that the reported issue could not be replicated and the system functioned as designed. The system then passed the system checkout and was found to be fully functional. Other relevant device(s) are: product id: 29631, serial/lot #: (b)(4); product id: 9735737, serial/lot #: unk. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186590771]
Medtronic received information that, while in a catheter placement procedure, the automated trajectory guidance unit could not connect to the navigation system. It was reported that the guidance unit was viewing a network but not the navigation system. The guidance unit was rebooted, where administrative settings were entered, network utility was opened, but an error message stating "retrieving firewall status timed out" on the system. When attempting to re-configure the settings, the configuration would disappear. Fully rebooting the guidance unit after leaving it off for a few minutes allowed the configuration to be viewed and the guidance unit could be connected to the navigation system. There was a reported delay to the procedure of forty minutes due to this issue. There was no reported impact on patient outcome. It was noted that the catheter being placed was for a medtronic thermal therapy system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01105 |
| MDR Report Key | 9898204 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-11-06 |
| Date Added to Maude | 2020-03-30 |
| 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 | S8 PREMIUM STEALTHSTATION NAVIGATION SYSTEM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-30 |
| Model Number | 9735665 |
| Catalog Number | 9735665 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-30 |