Brand Name | INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER |
Type of Device | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) |
302 parkway |
la aurora |
heredia |
CS |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) |
302 parkway |
la aurora |
heredia |
CS
|
|
Manufacturer Contact |
linda
leimer
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 5237715 |
MDR Text Key | 31662411 |
Report Number | 2134265-2015-08032 |
Device Sequence Number | 1 |
Product Code |
OAD
|
Combination Product (y/n) | N |
Reporter Country Code | AU |
PMA/PMN Number | P020025 |
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 |
Report Date |
11/03/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/21/2018 |
Device Model Number | M004EPM4500N40 |
Device Catalogue Number | EPM4500N4 |
Device Lot Number | 17614450 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/25/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/03/2015
|
Initial Date FDA Received | 11/19/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/05/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |