Brand Name | PULSE GEN MODEL 106 |
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 | 6996660 |
MDR Text Key | 90882406 |
Report Number | 1644487-2017-04720 |
Device Sequence Number | 1 |
Product Code |
LYJ
|
UDI-Device Identifier | 05425025750061 |
UDI-Public | 05425025750061 |
Combination Product (y/n) | N |
Reporter Country Code | CO |
PMA/PMN Number | P970003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
03/20/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 01/12/2019 |
Device Model Number | 106 |
Device Lot Number | 5183 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Event Location |
Other
|
Initial Date Manufacturer Received |
10/18/2017 |
Initial Date FDA Received | 11/02/2017 |
Supplement Dates Manufacturer Received | 11/16/2017 01/31/2018 02/27/2018
|
Supplement Dates FDA Received | 12/12/2017 02/21/2018 03/20/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/07/2017 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 9 YR |