Brand Name | ATTAIN VENOGRAM BALLOON CATHETER |
Type of Device | CATHETER, FLOW DIRECTED |
Manufacturer (Section D) |
MEDTRONIC, INC. |
8200 coral sea street ne |
mounds view MN 55112 |
|
Manufacturer (Section G) |
MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
8200 coral sea st ne |
|
mounds view MN 55112 |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 4833377 |
MDR Text Key | 5908284 |
Report Number | 2182208-2015-02055 |
Device Sequence Number | 1 |
Product Code |
DYG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K012225 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative,company representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/28/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/10/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/09/2017 |
Device Model Number | 6215 |
Device Catalogue Number | 6215 |
Device Lot Number | 61415088 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/04/2015 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/23/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/16/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | 693558 LEAD, 5076-45 LEAD |
Patient Age | 00071 YR |