Brand Name | EASYTRAK LVA |
Type of Device | IMPLANTABLE LEAD |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
4100 hamline avenue north |
saint paul MN 55112 |
|
Manufacturer (Section G) |
CPI - DEL CARIBE |
guidant puerto rico b. v. |
#12, rd. #698 |
dorado PR 00646 |
|
Manufacturer Contact |
timothy
degroot
|
4100 hamline avenue north |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 16361823 |
MDR Text Key | 309372177 |
Report Number | 2124215-2023-06121 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010012/S010 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
02/16/2023 |
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 | 07/08/2006 |
Device Model Number | 4538 |
Device Catalogue Number | 4538 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/24/2023 |
Initial Date FDA Received | 02/13/2023 |
Supplement Dates Manufacturer Received | 02/14/2023
|
Supplement Dates FDA Received | 02/16/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/08/2004 |
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;
Required Intervention;
|
Patient Age | 92 YR |
Patient Sex | Female |
|
|