Brand Name | VIGILANT |
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 |
tim
degroot
|
4100 hamline ave. n |
st. paul, MN
|
6515826168
|
|
MDR Report Key | 7766556 |
MDR Text Key | 116523918 |
Report Number | 2124215-2018-15203 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 00802526589287 |
UDI-Public | 00802526589287 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
06/14/2018 |
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 | 08/16/2019 |
Device Model Number | G247 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
06/14/2018
|
Initial Date FDA Received | 08/09/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/16/2017 |
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 | 0292; 0940; 1230; 1294; 4076; 4261; 4504; 4672; G247 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 65 YR |