Brand Name | ENSITE¿ PRECISION¿ SOFTWARE |
Type of Device | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
one st. jude medical drive |
st. paul MN 55117 |
|
MDR Report Key | 8305472 |
MDR Text Key | 135017553 |
Report Number | 2184149-2019-00014 |
Device Sequence Number | 1 |
Product Code |
DQK
|
Combination Product (y/n) | N |
PMA/PMN Number | K160210 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
03/13/2019 |
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 | H702496 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/15/2019 |
Initial Date FDA Received | 02/05/2019 |
Supplement Dates Manufacturer Received | 03/12/2019
|
Supplement Dates FDA Received | 03/13/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|