Brand Name | EASYTRAK 2 |
Type of Device | IMPLANTABLE LEAD |
Manufacturer (Section D) |
CPI - DEL CARIBE |
guidant puerto rico b. v. |
dorado PR |
|
Manufacturer (Section G) |
CPI - DEL CARIBE |
guidant puerto rico b. v. |
|
dorado PR |
|
Manufacturer Contact |
sonali
vasekar
|
4100 hamline ave. n |
st. paul, MN
|
6515824786
|
|
MDR Report Key | 6261541 |
MDR Text Key | 65143905 |
Report Number | 2124215-2016-19515 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 00802526417672 |
UDI-Public | (01)00802526417672(17)20110623 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010012/S024 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/01/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/18/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 06/23/2011 |
Device Model Number | 4518 |
Other Device ID Number | EASYTRAK 2 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Manufacturer Received | 11/01/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/23/2009 |
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 | 0185; 1290; 4136; 4469; 4518; 4525; N118 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 64 YR |