Brand Name | INOGEN |
Type of Device | IMPLANTABLE CHF GENERATOR |
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 |
tim
degroot
|
4100 hamline ave. n |
st. paul, MN
|
6515824786
|
|
MDR Report Key | 6486649 |
MDR Text Key | 72583088 |
Report Number | 2124215-2017-05491 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 00802526534591 |
UDI-Public | (01)00802526534591(17)20170324 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
study |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/17/2017 |
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 | 03/24/2017 |
Device Model Number | G148 |
Other Device ID Number | INOGEN X4 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 |
03/17/2017
|
Initial Date FDA Received | 04/12/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/24/2015 |
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 | (B)(4); (B)(4); (B)(4); (B)(4) |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 51 YR |