Brand Name | FREESTYLE AORTIC ROOT BIOPROSTHESIS |
Type of Device | HEART-VALVE, NON-ALLOGRAFT TISSUE |
Manufacturer (Section D) |
MEDTRONIC HEART VALVES DIVISION |
1851 e deere ave |
santa ana CA 92705 |
|
Manufacturer (Section G) |
MEDTRONIC HEART VALVES DIVISION |
1851 e deere ave |
|
santa ana CA 92705 |
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
EI
|
091708734
|
|
MDR Report Key | 12181553 |
MDR Text Key | 261964165 |
Report Number | 2025587-2021-02218 |
Device Sequence Number | 1 |
Product Code |
LWR
|
UDI-Device Identifier | 00681490816465 |
UDI-Public | 00681490816465 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P970031 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/16/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | FR995-29 |
Device Catalogue Number | FR995-29 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/22/2021
|
Initial Date FDA Received | 07/16/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 58 YR |
Patient Weight | 77 |