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 2020-03-31 for FREESTYLE AORTIC ROOT BIOPROSTHESIS FR995-23 manufactured by Medtronic Heart Valves Division.
[187856255]
Product analysis: the device remains implanted; therefore, no product analysis can be performed. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure and can be resolved with medical treatment or the implant of a permanent pacemaker. A conduction disturbance does not indicate a device malfunction or potential manufacturing issue. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187856256]
Medtronic received information that 3 days post implant of this aortic bioprosthetic valve, a permanent pacemaker was implanted. The reason for the permanent pacemaker was not reported. No additional adverse patient effects were reported.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-01035 |
| MDR Report Key | 9904443 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2011-04-29 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2010-11-03 |
| Date Added to Maude | 2020-03-31 |
| 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 VALVES 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 | FREESTYLE AORTIC ROOT BIOPROSTHESIS |
| Generic Name | HEART-VALVE, NON-ALLOGRAFT TISSUE |
| Product Code | LWR |
| Date Received | 2020-03-31 |
| Model Number | FR995-23 |
| Catalog Number | FR995-23 |
| Device Expiration Date | 2015-10-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
| Manufacturer Address | 1851 E DEERE AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |