FDA Adverse Event
Malfunction
Summary report: N
NCP BIPOLAR LEAD
MDR report key: 612002
·
Received September 29, 2004
Report
- Report Number
- 1644487-2004-00840
- Event Type
- Malfunction
- Date Received
- September 29, 2004
- Report Date
- August 30, 2004
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DEVICE DIAGNOSTIC TESTING RESULTED IN HIGH LEAD IMPEDANCE READING, INDICATING POSSIBLE DEVICE MALFUNCTION. IT WAS ALSO REPORTED THAT THE PATIENT NO LONGER FEELS DEVICE STIMULATION. PHYSICIAN INDICATED THAT NCP SYSTEM REPLACEMENT SURGERY WAS PLANNED AND THAT THE PATIENT DID NOT EXPERIENCE ANY INJURY OR TRAUMA THAT MAY HAVE DAMAGED THE NCP SYSTEM. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT UNDERWENT NCP SYSTEM REPLACEMENT. NEUROSURGEON INDICATED THAT THE PATIENT IS DOING WELL SINCE NCP SYSTEM REPLACEMENT. LEAD BREAK IS SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP BIPOLAR LEAD | BIPOLAR LEAD | LYJ | CYBERONICS, INC. | 300-20 | 3980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |