Brand Name | ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT |
Type of Device | ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
one st. jude medical drive |
st. paul MN 55117 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC. |
one st. jude medical drive |
|
st. paul MN 55117 |
|
Manufacturer Contact |
denise
johnson
|
5050 nathan lane north |
plymouth, MN 55442
|
6517564470
|
|
MDR Report Key | 6543617 |
MDR Text Key | 74399212 |
Report Number | 2184149-2017-00008 |
Device Sequence Number | 1 |
Product Code |
DQK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K160186 |
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 |
05/04/2017 |
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 | EN0020-P |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/18/2017 |
Initial Date FDA Received | 05/04/2017 |
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 |
Patient Outcome(s) |
Other;
|