FDA Adverse Event
Injury
Summary report: N
NCP PULSE GENERATOR
MDR report key: 497015
·
Received November 19, 2003
Report
- Report Number
- 1644487-2003-00781
- Event Type
- Injury
- Date Received
- November 19, 2003
- Date of Event
- October 1, 2003
- Report Date
- October 23, 2003
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT PT HAS BEEN EXPERIENCING HEART PALPITATIONS. THE PT DID NOT KNOW WHETHER THE HEART PALPITATIONS COINCIDED WITH STIMULATION. IT WAS REPORTED THAT THE PALPITATIONS BEGAN WITHIN A FEW WEEKS OF PARAMETER INCREASE. THE PT HAS REPORTEDLY BEEN SEEN BY THEIR NEUROLOGIST SINCE THE PALPITATIONS BEGAN, BUT NO INTERVENTION HAS BEEN TAKEN TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP PULSE GENERATOR | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 101 | 4399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Life Threatening | EXPIR DATE 04/30/01, DATE OF MFG 04/07/99,| MODEL 300-20 NCP BIPOLAR LEAD,| STERILIZATION LOT NO. 21447C, IMPLANTED 2000. |