Brand Name | LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE |
Type of Device | CATHETER, STEERABLE |
Manufacturer (Section D) |
ST. JUDE MEDICAL |
14901 deveau place |
minnetonka MN 55345 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL |
14901 deveau place |
|
minnetonka MN 55345 |
|
Manufacturer Contact |
janna
parks
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 12238136 |
MDR Text Key | 263812801 |
Report Number | 2182269-2021-00062 |
Device Sequence Number | 1 |
Product Code |
DRA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K022380 |
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 |
07/28/2021 |
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 Model Number | 401904 |
Device Catalogue Number | 401904 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/01/2021 |
Initial Date FDA Received | 07/28/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Treatment | LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER; TACTICATH¿ ABLATION CATHETER, SENSOR ENABLED |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 77 YR |
Patient Weight | 60 |