FDA Adverse Event
Injury
Summary report: N
DEMIPULSE GEN MODEL 103
MDR report key: 1936143
·
Received December 13, 2010
Report
- Report Number
- 1644487-2010-02781
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 10, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED BY THE HOSPITAL NURSE THAT THE PT HAD HIS GENERATOR REPLACED BECAUSE THE DEVICE WAS "SHOCKING THE PT OR DOING SOMETHING BAD, THAT IT WAS NOT SUPPOSE TO." NO ADDITIONAL INFO WAS PROVIDED. PATIENT'S EXPLANTED GENERATOR WAS RETURNED TO MANUFACTURER FOR ANALYSIS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL TILL DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEMIPULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 200926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Required Intervention |