Brand Name | SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND |
Type of Device | RING, ANNULOPLASTY |
Manufacturer (Section D) |
MEDTRONIC HEART VALVE DIVISION |
1851 e deere ave |
santa ana,ca |
|
Manufacturer (Section G) |
MEDTRONIC HEART VALVE DIVISION |
1851 e deere ave |
|
santa ana,ca |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea street ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 7382190 |
MDR Text Key | 103854622 |
Report Number | 2025587-2018-00730 |
Device Sequence Number | 1 |
Product Code |
KRH
|
UDI-Device Identifier | 00643169182370 |
UDI-Public | 00643169182370 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K052899 |
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 |
04/06/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/29/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/24/2022 |
Device Model Number | 700FC |
Device Catalogue Number | 700FC31 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/02/2018 |
Date Device Manufactured | 11/24/2017 |
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 | 81 YR |
Patient Weight | 86 |
|
|