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 2020-03-27 for STEALTHSTATION S7 9733856 manufactured by Medtronic Navigation, Inc.
[185249062]
Other relevant device(s) are: product id: 9735585, version: 3. 0. 2. 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
[185249063]
Medtronic received information regarding a navigation system being used for a cranial resection procedure. It was reported that during the case there were issues tracking the passive planar instrument. The non-sterile passive planar probe was able to be verified with no issue, but when navigating the sterile instrument, the passive planar was not navigating. The site would see nothing tracking when a passive planar probe was brought into view until they re-centered the image. The probe was then able to be seen in the tracking view and the site was able to verify the instrument. This behavior was consistent using two different passive planar probes. It was noted that all other instruments tracked and navigated as intended. There was a less than 1 hour delay to the procedure and no impact to patient outcome as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01090 |
| MDR Report Key | 9889055 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| 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 S7 |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-27 |
| Model Number | 9733856 |
| Catalog Number | 9733856 |
| 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 |