FDA Adverse Event
Injury
Summary report: N
NCP PULSE GENERATOR
MDR report key: 585262
·
Received March 25, 2005
Report
- Report Number
- 1644487-2005-00195
- Event Type
- Injury
- Date Received
- March 25, 2005
- Date of Event
- February 1, 2005
- Report Date
- February 24, 2005
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THE PT WAS PREGNANT AND HAD STARTED BLEEDING WITH LOWER STOMACH PAINS. IT WAS LATER REPORTED THAT THE PT EXPERIENCED A MISCARRIAGE. IT WAS ALSO REPORTED THAT THE PT HAS NOT BEEN ON SEIZURE MEDICATIONS FOR APPROXIMATELY 4 YEARS AND HAS BEEN SEIZURE FREE WITH THE NCP SYSTEM. THE PT HAD DOWN SYNDROME WHICH IS THE LIKELY CAUSE OF THE MISCARRIAGE. THERE IS NO EVIDENCE AT THIS TIME THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP PULSE GENERATOR | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 101 | 4919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other | MODEL 300-20 BIPOLAR LEAD, ECPIR DATE 05/00| DATE OF MFG. 05/98, STERILIZATION LOT # 114969| IMPLANT DATE 1999 |