FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1070003
·
Received July 2, 2008
Report
- Report Number
- 1644487-2008-01502
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 3, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SITE WAS EXPERIENCING PROBLEMS WITH THE PROGRAMMING SYSTEM. THE WAND COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR DURING TROUBLESHOOTING. THE WAND WAS SUBSEQUENTLY RETURNED TO MFR FOR ANALYSIS. ANALYSIS OF THE DEVICE REVEALED THAT THE SERIAL DATA CABLE, WHICH PRODUCED COMMUNICATION ERRORS, HAD INTERMITTENT CONDUCTORS. A KNOWN GOOD BENCH SERIAL DATA CABLE WAS SUBSTITUTED AND ALL COMMUNICATIONS ERRORS CLEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING WAND | LYJ | CYBERONICS, INC. | 201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |