Brand Name | PROGRAMMING SOFTWARE |
Type of Device | PROGRAMMING COMPUTER |
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 | 3892490 |
MDR Text Key | 4723289 |
Report Number | 1644487-2014-01581 |
Device Sequence Number | 1 |
Product Code |
LYJ
|
Combination Product (y/n) | N |
Reporter Country Code | IS |
PMA/PMN Number | P970003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
05/27/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | MODEL 250 |
Device Lot Number | 1063833 |
Other Device ID Number | VERSION 8.1 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/22/2014 |
Is the Reporter a Health Professional? |
Yes
|
Event Location |
Other
|
Initial Date Manufacturer Received |
09/07/2014 |
Initial Date FDA Received | 06/24/2014 |
Supplement Dates Manufacturer Received | Not provided Not provided Not provided
|
Supplement Dates FDA Received | 07/18/2014 08/21/2014 09/30/2014
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/24/2008 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |