MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-27 for STEALTH S8 PREMIUM 9735665 manufactured by Medtronic Navigation, Inc.
[185248004]
Other relevant device(s) are: product id: 9735740, version: 1. 2. 0. A medtronic representative went to the site to test the equipment. Testing revealed that the system performed as intended and passed a system checkout. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185248005]
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that while setting up for a case, the reference frame could not be tracked. The frame was correctly added to the instruments page, and the spheres were swapped with working spheres from a tracker with no resolution. It was noted that the site had a non-sterile cranial frame. Troubleshooting was performed by rebooting the system, and the system was then able to track the reference frame. There was no patient involved when this issue was discovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01088 |
| MDR Report Key | 9888985 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2018-12-13 |
| 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 | STEALTH S8 PREMIUM |
| 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 |