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 55112
|
6515824786
|
|
MDR Report Key | 4409696 |
MDR Text Key | 5279496 |
Report Number | 2124215-2015-00103 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
PMA/PMN Number | P010012 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/11/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/12/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 06/07/2016 |
Device Model Number | 4542 |
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 | 11/11/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/07/2014 |
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 | 4470; 3400; 5076; 4542; 1010; V273 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 64 YR |