FDA Adverse Event
Malfunction
Summary report: N
NCP BIPOLAR LEAD
MDR report key: 515688
·
Received March 13, 2004
Report
- Report Number
- 1644487-2004-00173
- Event Type
- Malfunction
- Date Received
- March 13, 2004
- Report Date
- February 13, 2004
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT), INDICATING POSSIBLE DEVICE MALFUNCTION. THE ELECTIVE REPLACEMENT INDICATOR WAS NO, INDICATING THE GENERATOR HAD NOT REACHED END OF SERVICE. IT WAS REPORTED THAT THE PATIENT HAD RECENTLY EXPERIENCED AN INCREASE IN SEIZURE ACTIVITY AND MAY HAVE FALLEN WITH ONE OF THEIR SEIZURES, POTENTIALLY CAUSING DAMAGE TO THE NCP SYSTEM. REVIEW OF X-RAYS BY RADIOLOGIST REVEALED NO OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. THE DEVICE WAS PROGRAMMED TO OFF PENDING NCP SYSTEM REPLACEMENT SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP BIPOLAR LEAD | BIPOLAR LEAD | LYJ | CYBERONICS, INC. | 300-20 | 23345C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | PHENYTOIN ER, KEPPRA.| MEDICATIONS AT TIME OF EVENT INCLUDE: PHENYTEK,| MODEL 100 NCP PULSE GENERATOR, EXPIR DATE 10/31/00| DATE OF MFG 5/11/1999, STERILIZATION LOT#. 22821C. |