MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-08-29 for IMAGING SYSTEM UNK_OARM_SYS manufactured by Medtronic Navigation, Inc (littleton).
| Report Number | 3004785967-2019-01537 |
| MDR Report Key | 8946704 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-08-29 |
| Date of Report | 2019-08-29 |
| Date of Event | 2017-12-16 |
| Date Mfgr Received | 2019-07-31 |
| Date Added to Maude | 2019-08-29 |
| 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 (LITTLETON) |
| Manufacturer Street | 300 FOSTER ST |
| Manufacturer City | LITTLETON MA 01460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMAGING SYSTEM |
| Product Code | JAA |
| Date Received | 2019-08-29 |
| Model Number | UNK_OARM_SYS |
| Catalog Number | UNK_OARM_SYS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Manufacturer Address | 300 FOSTER ST LITTLETON MA 01460 US 01460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-29 |