Brand Name | ENERGEN |
Type of Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
Manufacturer (Section D) |
GUIDANT CRM CLONMEL IRELAND |
guidant ireland |
clonmel, tipperary ireland |
|
Manufacturer (Section G) |
GUIDANT CRM CLONMEL IRELAND |
guidant ireland |
|
clonmel, tipperary ireland |
|
Manufacturer Contact |
sonali
vasekar
|
4100 hamline ave. n |
st. paul, MN 55112
|
6515824786
|
|
MDR Report Key | 4887957 |
MDR Text Key | 6537181 |
Report Number | 2124215-2015-08111 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/12/2015 |
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 |
Lay User/Patient
|
Device Expiration Date | 12/12/2015 |
Device Model Number | N140 |
Other Device ID Number | ENERGEN CRT-D |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
06/12/2015
|
Initial Date FDA Received | 07/02/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/18/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | 4470; N140; 4543; 0296 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 76 YR |
|
|