FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 101
MDR report key: 2160828
·
Received July 7, 2011
Report
- Report Number
- 1644487-2011-01519
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 7, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA CLINIC NOTES RECEIVED THAT THE PT'S SEIZURES WERE SLIGHTLY INCREASED. THE PHYSICIAN INDICATED THAT THE GENERATOR IS 9 YEARS OLD AND STILL WORKING. THE PT WAS REFERRED FOR GENERATOR REPLACEMENT. SURGERY TO REPLACE THE PT'S GENERATOR HAS OCCURRED. ATTEMPTS FOR FURTHER INFO AND THE RETURN OF THE PT'S GENERATOR ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 4533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |