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 2020-03-30 for S8 ENT STEALTHSTATION NAVIGATION SYSTEM 9735669 manufactured by Medtronic Navigation, Inc.
[188826171]
Patient age not available from the site. Patient weight not available from the site. No parts have been received by the manufacturer for evaluation. Concomitant medical products: product id: 9735521, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188826172]
Medtronic received information that, while in a temporal lobe tumor procedure, inflammation was observed around the midline of the lower jaw skin. It was reported that the issue occurred after about seven hours of the procedure. It was reported that there was no direct contact on the patient with the emitter. Additionally it was suspected that the emitter contributed to the inflammation. There was no reported delay to the procedure due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01102 |
| MDR Report Key | 9897540 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-25 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2018-12-18 |
| 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 ENT STEALTHSTATION NAVIGATION SYSTEM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-30 |
| Model Number | 9735669 |
| Catalog Number | 9735669 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2020-03-30 |