Brand Name | EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR |
Type of Device | PROGRAMMABLE DIAGNOSTIC COMPUTER |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
one st. jude medical drive |
st. paul MN 55117 |
|
MDR Report Key | 8791121 |
MDR Text Key | 151052544 |
Report Number | 2184149-2019-00131 |
Device Sequence Number | 1 |
Product Code |
DQK
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup |
Report Date |
10/14/2019 |
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 | H403023 |
Device Lot Number | 6386966 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/04/2019 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/01/2019
|
Initial Date FDA Received | 07/15/2019 |
Supplement Dates Manufacturer Received | 07/31/2019 10/11/2019
|
Supplement Dates FDA Received | 07/31/2019 10/14/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|