Brand Name | TRANSSEPTAL NEEDLE, BRK SERIES |
Type of Device | TRANSSEPTAL NEEDLE |
Manufacturer (Section D) |
ST. JUDE MEDICAL |
parque industrial, zona franca coyol s.a. |
edificio #44b, calle 0, avenida 2, coyol |
alajuela 1897- 4050 |
CS 1897-4050 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL |
parque industrial, zona franca coyol s.a. |
edificio #44b, calle 0, avenida 2, coyol |
alajuela 1897- 4050 |
CS
1897-4050
|
|
MDR Report Key | 5276178 |
MDR Text Key | 32985017 |
Report Number | 3008452825-2015-00112 |
Device Sequence Number | 1 |
Product Code |
DRC
|
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | K072278 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
11/09/2015 |
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 Expiration Date | 05/31/2018 |
Device Model Number | 407201 |
Device Lot Number | 5114909 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/09/2015 |
Initial Date FDA Received | 12/08/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/21/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/08/2015 |
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) |
Other;
|
|
|