Brand Name | PULSE GEN MODEL 103 |
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 | 7623285 |
MDR Text Key | 111875780 |
Report Number | 1644487-2018-01044 |
Device Sequence Number | 1 |
Product Code |
LYJ
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | P970003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,OTHER |
Reporter Occupation |
OTHER CAREGIVERS
|
Type of Report
| Initial,Followup |
Report Date |
01/25/2019 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 06/20/2018 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
LAY USER/PATIENT
|
Device EXPIRATION Date | 10/31/2015 |
Device MODEL Number | 103 |
Device LOT Number | 3799 |
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 | 01/02/2019 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 11/20/2013 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|