Brand Name | PULSE GEN MODEL 104 |
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 |
dana
sprague
|
100 cyberonics blvd |
suite 600 |
houston, TX 77058
|
2816672681
|
|
MDR Report Key | 10889014 |
MDR Text Key | 217938475 |
Report Number | 1644487-2020-01581 |
Device Sequence Number | 1 |
Product Code |
LYJ
|
UDI-Device Identifier | 05425025750047 |
UDI-Public | 05425025750047 |
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 |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup,Followup |
Report Date |
09/14/2022 |
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 | 09/20/2019 |
Device Model Number | 104 |
Device Lot Number | 5495 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Event Location |
Other
|
Initial Date Manufacturer Received |
10/01/2020
|
Initial Date FDA Received | 11/23/2020 |
Supplement Dates Manufacturer Received | 12/15/2020 12/27/2021 08/11/2022 08/22/2022
|
Supplement Dates FDA Received | 12/16/2020 01/21/2022 08/19/2022 09/14/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/25/2017 |
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) |
Other;
|
Patient Age | 52 YR |
Patient Sex | Female |