Brand Name | ENSITE PRECISION POWER CABLE |
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 | 9531935 |
MDR Text Key | 191763507 |
Report Number | 2184149-2019-00258 |
Device Sequence Number | 1 |
Product Code |
DQK
|
UDI-Device Identifier | 05415067024756 |
UDI-Public | 05415067024756 |
Combination Product (y/n) | N |
PMA/PMN Number | K183128 |
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 |
02/06/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 100143451 |
Device Catalogue Number | H702475 |
Device Lot Number | 6859138 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/24/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/13/2019 |
Initial Date FDA Received | 12/30/2019 |
Supplement Dates Manufacturer Received | 01/08/2020
|
Supplement Dates FDA Received | 02/06/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|