FDA Adverse Event
Injury
Summary report: N
NCP PULSE GENERATOR
MDR report key: 429453
·
Received November 21, 2002
Report
- Report Number
- 1644487-2002-00503
- Event Type
- Injury
- Date Received
- November 21, 2002
- Date of Event
- October 24, 2002
- Report Date
- November 6, 2002
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PATIENT'S NCP SYSTEM WAS EXPLANTED DUE TO LACK OF EFFICACY AND INFECTION. THE DEVICE WAS PROGRAMMED TO OFF IN 2002, DUE TO LACK OF EFFICACY. THE INFECTION WAS FIRST NOTED 8 MO LATER AT THE BIPOLAR LEAD/CERVICAL AREA, AND WAS TREATED WITH ANTIBIOTICS AND EXPLANT OF NCP SYSTEM. THE INFECTION IS RESOLVED AND RE-IMPLANT IS NOT SCHEDULED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP PULSE GENERATOR | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 101 | 4398 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Hospitalization| R | EXPIR DATE 01/31/2003, DATE OF MFG 01/30/2001,| STERILIZATION LOT NO. 2061.| 1) MODEL 300-20 NCP BIPOLAR LEAD, |