Brand Name | PULSE GEN MODEL 106 |
Type of Device | GENERATOR |
Manufacturer (Section D) |
LIVANOVA USA, INC. |
100 cyberonics blvd |
houston TX 77058 |
|
Manufacturer (Section G) |
LIVANOVA USA, INC. |
100 cyberonics blvd |
suite 600 |
houston TX 77058 |
|
Manufacturer Contact |
rachel
kohn
|
100 cyberonics blvd |
suite 600 |
houston
, TX 77058
|
2812287200
|
|
MDR Report Key | 8364063 |
Report Number | 1644487-2019-00350 |
Device Sequence Number | 1 |
Product Code | LYJ |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,FOREIG |
Reporter Occupation |
|
Type of Report
| Initial |
Report Date |
03/20/2019 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 02/22/2019 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
LAY USER/PATIENT
|
Device MODEL Number | 106 |
Device LOT Number | 204429 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
Other
|
Date Manufacturer Received | 02/27/2019 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 03/28/2018 |
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: 02/22/2019 Patient Sequence Number: 1 |
|
|