FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1191492
·
Received September 26, 2008
Report
- Report Number
- 1644487-2008-02348
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- August 27, 2008
- Report Date
- August 27, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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
THE REPORTER INDICATED THAT HE WAS UNABLE TO PLACE A LEAD ON A PATIENT'S VAGUS NERVE AS THE HELICAL WAS UNABLE TO BE OPENED. A NEW LEAD WAS IMPLANTED AND THE SUSPECT DEVICE WAS RETURNED TO THE MANUFACTURER WHERE IT IS CURRENTLY AWAITING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 200417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |