MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for STEALTHSTATION S8 PREMIUM SYSTEM 9735665 manufactured by Medtronic Navigation, Inc.
[186751608]
Concomitant medical products: other relevant device(s) are: product id: 9735999 , serial/lot : (b)(4), udi: (b)(4). A medtronic representative went to the site to test the equipment. The issue was confirmed. The ssd was replaced. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186751609]
Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure. During the procedure, an error message displayed on the navigation system when a navigated scan was sent from the imaging system. A second image acquisition and push resulted in the same error. The procedure was completed by using a second navigation system. Since the second navigation could receive the image, the imaging system was ruled out as fault. It was confirmed the correct images were being sent to the navigation system. The issue resulted in less than one hour procedure delay. Additional information received indicated the system software and hardware resolved the reported issue. The cause of the reported error message was likely related to having too many patient exams (dating back 18 months that degraded), a bad file name was pushed from the imaging system (used picture archiving and communication systems worklists to collect patient information), or the navigation system was "shut down hard" (site staff did not recall this happening).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01096 |
| MDR Report Key | 9892298 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-08-16 |
| Date Added to Maude | 2020-03-27 |
| 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 PREMIUM SYSTEM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-27 |
| 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 | 2020-03-27 |