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 2020-03-29 for SJM REGENT HEART VALVE W/FLEX CUFF 21AGFN-756 manufactured by St. Jude Medical Puerto Rico, Inc..
| Report Number | 2648612-2020-00039 |
| MDR Report Key | 9896103 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-08-13 |
| Date Added to Maude | 2020-03-29 |
| 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 | PAMELA YIP |
| Manufacturer Street | 5050 NATHAN LANE N |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL PUERTO RICO, INC. |
| Manufacturer Street | P.O. BOX 998 LOT 20 B ST. |
| Manufacturer City | CAGUAS, PUERTO RICO 00725 |
| Manufacturer Country | RQ |
| Manufacturer Postal Code | 00725 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SJM REGENT HEART VALVE W/FLEX CUFF |
| Generic Name | HEART-VALVE, MECHANICAL |
| Product Code | LWQ |
| Date Received | 2020-03-29 |
| Model Number | 21AGFN-756 |
| Catalog Number | 21AGFN-756 |
| Lot Number | 6587165 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL PUERTO RICO, INC. |
| Manufacturer Address | P.O. BOX 998 LOT 20 B ST. CAGUAS, PUERTO RICO 00725 RQ 00725 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-29 |