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 2019-11-29 for RESOLUTE ONYX RX RONYX25022X manufactured by Medtronic Ireland.
| Report Number | 9612164-2019-04955 |
| MDR Report Key | 9391809 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-29 |
| Date of Report | 2019-11-29 |
| Date of Event | 2018-09-22 |
| Date Mfgr Received | 2019-11-14 |
| Device Manufacturer Date | 2017-12-29 |
| Date Added to Maude | 2019-11-29 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOLUTE ONYX RX |
| Generic Name | STENT, CORONARY, DRUG-ELUTING |
| Product Code | NIQ |
| Date Received | 2019-11-29 |
| Catalog Number | RONYX25022X |
| Lot Number | 0009010657 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-11-29 |