Brand Name | FREESTYLE |
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 |
paula
bixby
|
8200 coral sea street ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 7126167 |
MDR Text Key | 95172394 |
Report Number | 2025587-2017-02481 |
Device Sequence Number | 1 |
Product Code |
LWR
|
UDI-Device Identifier | 10681490265918 |
UDI-Public | 10681490265918 |
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,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/20/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/18/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/15/2009 |
Device Model Number | FR99525 |
Device Catalogue Number | FR99525 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/05/2017 |
Date Device Manufactured | 06/15/2004 |
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) |
Required Intervention;
|
Patient Age | 37 YR |
Patient Weight | 56 |
|
|