FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1040829
·
Received May 9, 2008
Report
- Report Number
- 1644487-2008-01100
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 29, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED.
Description of Event or Problem · 1
REPORTER INDICATED A PT HAD HIGH LEAD IMPEDANCE READINGS AT A ROUTINE OFFICE VISIT. THE PT ALSO REPORTED NOT FEELING ANY MAGNET STIMULATION FOR APPROX THREE MONTHS. THE PT USUALLY DID NOT FEEL HIS REGULAR VNS STIMULATION. NO TRAUMA OR DEVICE MANIPULATION WAS ADMITTED. THE VNS WAS DISABLED. X-RAYS REVIEWED BY THE MFR DID NOT IDENTIFY ANY OBVIOUS LEAD ANOMALIES. THE PT WILL BE FOLLOWED CLINICALLY FOR NOW. THE PT IS CONSIDERING VNS REVISION SURGERY AND WILL INFORM THE REPORTER IF SURGERY IS DESIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 30536C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |