Brand Name | AUTOGEN |
Type of Device | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
4100 hamline avenue north |
saint paul MN 55112 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CLONMEL LIMITED |
cashel road |
, |
clonmel |
EI
|
|
Manufacturer Contact |
timothy degroot
|
4100 hamline avenue north |
, |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 8794047 |
MDR Text Key | 151153429 |
Report Number | 2124215-2019-13603 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/16/2019 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 12/12/2016 |
Device Model Number | G179 |
Device Catalogue Number | G179 |
Device Lot Number | 128248 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/23/2019 |
Initial Date FDA Received | 07/16/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/12/2014 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 74 YR |