FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2012172
·
Received February 1, 2011
Report
- Report Number
- 1644487-2011-00152
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- December 19, 2010
- Report Date
- January 3, 2011
- 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 THAT THE PATIENT WOULD BE HAVING HER VNS LEAD AND GENERATOR REPLACED DUE TO AN UNKNOWN REASON. AN IMPLANT CARD WAS LATER RECEIVED AFTER REPLACEMENT INDICATING THAT THE REASON FOR REPLACEMENT WAS DUE TO A LEAD DISCONTINUITY. THE EXPLANTED LEAD AND GENERATOR HAVE BEEN RETURNED AND ARE CURRENTLY UNDERGOING ANALYSIS. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS. NO ADVERSE EVENTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 201033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |