Brand Name | PACEL FLOW DIRECTED PACING CATHETER |
Type of Device | ELECTRODE, PACEMAKER, TEMPORARY |
Manufacturer (Section D) |
ST. JUDE MEDICAL |
14901 deveau place |
minnetonka MN 55345 2126 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL |
14901 deveau place |
|
minnetonka MN 55345 2126 |
|
Manufacturer Contact |
denise
johnson
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 7401164 |
MDR Text Key | 104737337 |
Report Number | 2182269-2018-00051 |
Device Sequence Number | 1 |
Product Code |
LDF
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K161873 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
04/05/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/31/2019 |
Device Model Number | 401615 |
Device Catalogue Number | 401615 |
Device Lot Number | 6159647 |
Other Device ID Number | 05414734025546 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/16/2018 |
Initial Date FDA Received | 04/05/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/05/2017 |
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;
|