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 2020-03-25 for SJM? MECHANICAL HEART VALVE CVD0040 manufactured by St. Jude Medical Puerto Rico, Inc..
| Report Number | 2648612-2020-00029 |
| MDR Report Key | 9878406 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SJM? MECHANICAL HEART VALVE |
| Generic Name | HEART-VALVE, MECHANICAL |
| Product Code | LWQ |
| Date Received | 2020-03-25 |
| Model Number | CVD0040 |
| Catalog Number | CVD0040 |
| 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. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2020-03-25 |