Brand Name | INOGEN X4 CRT-D |
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 CORPORATION |
4100 hamline avenue north |
|
saint paul MN 55112 5798 |
|
Manufacturer Contact |
timothy
degroot
|
4100 hamline avenue north |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 9270337 |
MDR Text Key | 164823592 |
Report Number | 2124215-2019-23310 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 00802526534591 |
UDI-Public | 00802526534591 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010012/S341 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/02/2019 |
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 | 11/14/2019 |
Device Model Number | G148 |
Device Catalogue Number | G148 |
Device Lot Number | 182047 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/04/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/03/2019 |
Initial Date FDA Received | 11/02/2019 |
Date Device Manufactured | 11/29/2017 |
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 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 61 YR |