FDA Adverse Event
Other
Summary report: N
NCP PULSE GENERATOR
MDR report key: 468004
·
Received June 19, 2003
Report
- Report Number
- 1644487-2003-00359
- Event Type
- Other
- Date Received
- June 19, 2003
- Date of Event
- June 7, 2002
- Report Date
- May 20, 2003
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE REPORTER INFORMED THE COMPANY ABOUT ATTEMPTING TO SUE THE FORMER PHYSICIAN BECAUSE PATIENT FELT THAT THE PHYSICIAN WAS WRONG IN PRESCRIBING THE VNS DEVICE FOR THE PATIENT. THE REPORTER INDICATED THAT THE DEVICE WAS ACTIVATED AND PATIENT WAS STILL EXPERIENCING SEIZURES. PATIENT STOPPED TAKING THE MEDICATIONS AND SUFFERED A MEMORY LOSS. APPROXIMATELY, ONE WEEK AFTER PATIENT STOPPED TAKING THE MEDICAITONS, THE MEMORY BEGAN TO RETURN AND PATIENT WAS DEPRESSED; HOWEVER, PATIENT DID NOT HAVE ANY MORE SEIZURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP PULSE GENERATOR | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 101 | 5919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other | MFG DATE 10/2001, STERILIZATION LOT 4309| NCP BIPOLAR LEAD, MODEL 300-20, EXPIR DATE: 2003 |