MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-04 for SIMULUS SEMI-RIGID ANNULOPASTY RING 800SR32 manufactured by Medtronic Heart Valve Division.
[177611606]
Product analysis: no product was returned. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177611607]
Medtronic received information that 8 months post implant of this 32mm mitral annuloplasty ring, it was explanted and replaced with a 33mm bioprosthetic valve. The reason for the replacement was not reported. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00375 |
| MDR Report Key | 9665653 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-04 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC HEART VALVE DIVISION |
| Manufacturer Street | 1851 E DEERE AVE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMULUS SEMI-RIGID ANNULOPASTY RING |
| Generic Name | RING, ANNULOPLASTY |
| Product Code | KRH |
| Date Received | 2020-02-04 |
| Model Number | 800SR32 |
| Catalog Number | 800SR32 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC HEART VALVE DIVISION |
| Manufacturer Address | 1851 E DEERE AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-04 |