Brand Name | ENERGEN CRT-D |
Type of Device | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
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 | 7985326 |
MDR Text Key | 124359419 |
Report Number | 2124215-2018-60205 |
Device Sequence Number | 1 |
Product Code |
LWP
|
UDI-Device Identifier | 00802526480959 |
UDI-Public | 802526480959 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,study |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/15/2019 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 09/12/2015 |
Device Model Number | N140 |
Device Catalogue Number | N140 |
Device Lot Number | 111404 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/14/2018 |
Initial Date FDA Received | 10/19/2018 |
Supplement Dates Manufacturer Received | 01/16/2019
|
Supplement Dates FDA Received | 03/15/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/20/2013 |
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 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 83 YR |
Patient Weight | 101 |