Brand Name | IBI¿ 1400-CV CARDIOVERSION II SWITCH BOX |
Type of Device | SYSTEM, PACING, TEMPORARY, ACUTE, INTERNAL ATRIAL DEFIBRILLATION |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
2375 morse ave |
irvine CA 92614 |
|
MDR Report Key | 8315917 |
MDR Text Key | 135417632 |
Report Number | 2030404-2019-00008 |
Device Sequence Number | 1 |
Product Code |
MTE
|
Combination Product (y/n) | N |
PMA/PMN Number | P020052 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
04/05/2019 |
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 | 85432 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/10/2019 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/14/2019 |
Initial Date FDA Received | 02/07/2019 |
Supplement Dates Manufacturer Received | 04/02/2019
|
Supplement Dates FDA Received | 04/05/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|