FDA Adverse Event
Injury
Summary report: N
NCP PULSE GENERATOR
MDR report key: 443103
·
Received February 7, 2003
Report
- Report Number
- 1644487-2003-00028
- Event Type
- Injury
- Date Received
- February 7, 2003
- Date of Event
- June 1, 2002
- Report Date
- January 9, 2003
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FURTHER FOLLOW-UP REVEALED THAT THE PT UNDERWENT NCP SYSTEM EXPLANT DUE TO THE PREVIOUSLY REPORTED EVENTS. BOTH THE PULSE GENERATOR AND BIPOLAR LEAD (INCLUDING ELECTRODES) WERE REMOVED. THE PT IS A CANDIDATE FOR THERAPEUTIC BRAIN SURGERY AND HAS DECIDED TO UNDERGO THE SURGERY.
Description of Event or Problem · 1
PT'S NCP SYSTEM WAS EXPLANTED DUE TO INFECTION. INFECTIOUS DISEASE PHYSICIAN REPORTEDLY BELIEVES THAT THE PT MIGHT BE ALLERGIC TO THE MATERIAL THAT EITHER THE LEAD OR GENERATOR IS MADE OUT OF. FURTHER F/U REVEALED THAT THE PT HAS UNDERGONE FOUR SURGERIES IN THE PAST SIX MONTHS DUE TO TROUBLE WITH WOUND HEALING AFTER NCP SYSTEM REPLACEMENT SURGERY IN 2002.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP PULSE GENERATOR | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 101 | 4813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Hospitalization| R | CURRENT ANTI-EPILEPTIC MEDICATIONS: KEPPRA| (1250MG/DAY), TEGRETOL (1100MG/DAY),| 11/30/2003, DATE OF MFG 12/07/2001, STERILIZATION| LOT NO. 4758.| GABITRIL (40MG/DAY).| MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE| ZONEGRAN. |