FDA Adverse Event
Injury
Summary report: N
NCP PULSE GENERATOR
MDR report key: 435041
·
Received December 20, 2002
Report
- Report Number
- 1644487-2002-00564
- Event Type
- Injury
- Date Received
- December 20, 2002
- Date of Event
- November 1, 2002
- Report Date
- November 21, 2002
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT'S NCP SYSTEM WAS EXPLANTED BECAUSE THEY HAD LOST SOME WEIGHT AND WERE "BOTHERED" BY THE DEVICE. THE PT REPORTEDLY HAD SOME DISCOMFORT AT THE SITE AND REQUESTED THAT THE NCP SYSTEM BE EXPLANTED. INVESTIGATION TO DATE HAS BEEN UNABLE TO DETERMINE WHETHER THE WEIGHT LOSS WAS OF A SUFFICIENT AMOUNT TO CAUSE SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP PULSE GENERATOR | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 101 | 6055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| L| R | EXPIR DATE 02/29/2004, DATE OF MFG 02/13/2002,| STERILIZATION LOT NO. 5316.| BIPOLAR LEAD., MODEL 300-30 NCP BIPOLAR LEAD, |