FDA Adverse Event
Malfunction
Summary report: N
NCP BIPOLAR LEAD
MDR report key: 539536
·
Received March 26, 2004
Report
- Report Number
- 1644487-2004-00233
- Event Type
- Malfunction
- Date Received
- March 26, 2004
- Report Date
- February 25, 2004
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE READING, INDICATING POSSIBLE DEVICE MALFUNCTION. THE PT HAS NOT EXPERIENCED AN INCREASE IN SEIZURE ACTIVITY AND DENIES ANY RECENT INJURY OR TRAUMA THAT MAY HAVE DAMAGED THE NCP SYSTEM. X-RAYS REVIEWED BY RADIOLOGIST DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. 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 | 14663C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | STERILIZATION LOT NO. 5919,| EXPLANTED: 2002.| IMPLANTED: 1999,| IMPLANTED: 2002.| DATE OF MFG 4/29/2002,| 2. MODEL 100 NCP PULSE GENERATOR,| EXPIR DATE 4/30/2003,| 1. MODEL 101 NCP PULSE GENERATOR, |