FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 103
MDR report key: 12313634
·
Received August 12, 2021
Report
- Report Number
- 1644487-2021-01108
- Event Type
- Malfunction
- Date Received
- August 12, 2021
- Date of Event
- March 14, 2021
- Report Date
- March 20, 2023
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- UDI-DI
- 05425025750030
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
D2: CODE - CORRECTION - MUZ SHOULD HAVE BEEN REPORTED ON INITIAL MDR.
Description of Event or Problem · 0
FURTHER INFORMATION WAS RECEIVED CONFIRMING THE DEPRESSIVE EPISODE WAS NOT RELATED TO VNS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING MAJOR DEPRESSIVE EPISODE. THE RELATIONSHIP TO VNS WAS NOT PROVIDED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1210155 | PULSE GEN MODEL 103 | GENERATOR | LYJ | LIVANOVA USA, INC. | 103 | 300380 | 05425025750030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Male |