Brand Name | 86 CM LV LEAD |
Type of Device | DEFIB, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION (CRT-D) |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
15900 valley view court |
sylmar CA 91342 |
|
MDR Report Key | 9699835 |
MDR Text Key | 178778207 |
Report Number | 9699835 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/31/2019,08/20/2019 |
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
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/31/2019 |
Event Location |
Outpatient Diagnostic Facility
|
Date Report to Manufacturer | 02/12/2020 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 02/12/2020 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|