FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2090723
·
Received April 26, 2011
Report
- Report Number
- 1644487-2011-00898
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 27, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
OUR COUNTRY REPRESENTATIVE IN (B)(4) WAS CONTACTED BY A VNS TREATING PHYSICIAN WHO REPORTED THAT HE HAD A VNS PATIENT WITH HIGH LEAD IMPEDANCE AND THEIR X-RAY WAS NORMAL. THE PATIENT'S VNS HAS BEEN PROGRAMMED OFF AND AT THIS TIME SURGERY HAS NOT BEEN PLANNED, BUT IS LIKELY. GOOD FAITH ATTEMPTS HAVE BEEN MADE AND THUS FAR NO FURTHER INFORMATION HAS BEEN ATTAINED. IF FURTHER INFORMATION IS ATTAINED, ANOTHER REPORT WILL BE SENT. IF SURGERY IS PLANNED ATTEMPTS WILL BE MADE FOR THE EXPLANTED PRODUCT TO BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |