Brand Name | PULSE GEN MODEL 101 |
Manufacturer (Section D) |
CYBERONICS, INC. |
houston TX 77058 |
|
Manufacturer Contact |
nydia
grimes
|
100 cyberonics blvd. |
ste. 600 |
houston
, TX 77058
|
2812287200
|
|
MDR Report Key | 2230508 |
Report Number | 1644487-2011-01858 |
Device Sequence Number | 1 |
Product Code | LYJ |
Report Source |
Manufacturer
|
Source Type |
Foreign,Study,Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/14/2011 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 08/12/2011 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device EXPIRATION Date | 05/31/2003 |
Device MODEL Number | 101 |
Device LOT Number | 4813 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Date Manufacturer Received | 07/14/2011 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 12/01/2001 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient TREATMENT DATA |
Date Received: 08/12/2011 Patient Sequence Number: 1 |
|
|