Brand Name | LEAD MODEL 302 |
Type of Device | LEAD |
Manufacturer (Section D) |
CYBERONICS, INC. |
100 cyberonics blvd |
houston TX 77058 770 |
|
Manufacturer (Section G) |
CYBERONICS, INC. |
100 cyberonics blvd |
suite 600 |
houston TX 77058 |
|
Manufacturer Contact |
njemile
crawley
|
100 cyberonics blvd |
suite 600 |
houston, TX 77058
|
2812287200
|
|
MDR Report Key | 4230225 |
MDR Text Key | 5073897 |
Report Number | 1644487-2014-02946 |
Device Sequence Number | 1 |
Product Code |
LYJ
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | P970003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
HEALTH PROFESSIONAL
|
Type of Report
| Initial,Followup |
Report Date |
10/07/2014 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 11/06/2014 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
LAY USER/PATIENT
|
Device EXPIRATION Date | 05/31/2014 |
Device MODEL Number | 302-20 |
Device LOT Number | 2689 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Event Location |
Other
|
Date Manufacturer Received | 02/04/2015 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 05/24/2010 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|