Brand Name | OPEN PIVOT MECHANICAL HEART VALVE |
Type of Device | HEART-VALVE, MECHANICAL |
Manufacturer (Section D) |
MEDTRONIC, INC. |
3800 annapolis lane |
minneapolis MN 55447 |
|
Manufacturer (Section G) |
MEDTRONIC, INC. |
3800 annapolis lane |
|
minneapolis MN 55447 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea street ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 6999665 |
MDR Text Key | 90980658 |
Report Number | 3008592544-2017-00059 |
Device Sequence Number | 1 |
Product Code |
LWQ
|
UDI-Device Identifier | 00613994868961 |
UDI-Public | 00613994868961 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P990046 |
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 |
Report Date |
11/03/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/03/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/26/2015 |
Device Model Number | 500DM |
Device Catalogue Number | 500DM27 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/09/2017 |
Date Device Manufactured | 07/16/2008 |
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 | 56 YR |
Patient Weight | 107 |
|
|