FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1963856
·
Received December 22, 2010
Report
- Report Number
- 1644487-2010-02870
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- November 30, 2010
- Report Date
- December 1, 2010
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED BY A NEUROLOGIST THAT VNS PATIENT HAD HIGH IMPEDANCE DURING AN OFFICE VISIT. LAST KNOWN SETTINGS AND DIAGNOSTICS FROM MANUFACTURER'S PROGRAMMING HISTORY WERE WITHIN NORMAL LIMIT ON (B)(6) 2009. (B)(4) ATTEMPTS TO OBTAIN MORE INFORMATION REGARDING PATIENT FROM THE TREATING NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE. IT IS UNKNOWN IF THE VNS DEVICE WAS PROGRAMMED OFF AT THIS POINT. IT IS LIKELY THAT PATIENT WILL HAVE FULL REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS INC | 302-20 | 1528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |