Brand Name | PULSE GEN MODEL 102 |
Type of Device | GENERATOR |
Manufacturer (Section D) |
CYBERONICS, INC. |
100 cyberonics blvd |
houston TX 77058 |
|
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 | 4330779 |
Report Number | 1644487-2014-03326 |
Device Sequence Number | 1 |
Product Code | LYJ |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative,COMPANY REPRESENTATIVE |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/20/2014 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 12/15/2014 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device EXPIRATION Date | 07/31/2005 |
Device MODEL Number | 102 |
Device LOT Number | 008950 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
Other
|
Date Manufacturer Received | 06/24/2016 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 08/12/2003 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|