MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-27 for RIATA ACTIVE FIXATION 1580/65 manufactured by St. Jude Medical, Inc.(crm-sylmar).
| Report Number | 2017865-2019-17227 |
| MDR Report Key | 9387701 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-11-10 |
| Date Mfgr Received | 2019-11-12 |
| Device Manufacturer Date | 2003-11-05 |
| Date Added to Maude | 2019-11-27 |
| 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 | ELIZABETH BOLTZ |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIATA ACTIVE FIXATION |
| Generic Name | DEFIBRILLATION LEAD |
| Product Code | NVY |
| Date Received | 2019-11-27 |
| Model Number | 1580/65 |
| Lot Number | 0002203357 |
| Device Expiration Date | 2006-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-27 |