Brand Name | INGENIO |
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 | 6476829 |
MDR Text Key | 72280429 |
Report Number | 2124215-2017-04543 |
Device Sequence Number | 1 |
Product Code |
NKE
|
Combination Product (y/n) | N |
PMA/PMN Number | P030005/S079 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Type of Report
| Initial |
Report Date |
01/26/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/10/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 07/04/2014 |
Device Model Number | V173 |
Other Device ID Number | INVIVE |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Manufacturer Received | 01/26/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/10/2012 |
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 | 1296; 4473; 4474; 4538; MISMATCH; S606; V173 |
Patient Age | 89 YR |