FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 4120196
·
Received September 25, 2014
Report
- Report Number
- 1644487-2014-02488
- Event Type
- Injury
- Date Received
- September 25, 2014
- Date of Event
- August 28, 2014
- Report Date
- August 29, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A VERY BAD SEIZURE THE NIGHT PRIOR AND WANTS TO HAVE THE GENERATOR REPLACED AS SHE BELIEVES THE GENERATOR BATTERY IS DEAD. IT WAS ALSO REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING VERY BAD SEIZURES. THE PATIENT WAS SCHEDULED FOR GENERATOR REPLACEMENT. AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 598220 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS INC | 103 | 200981 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |