FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1191906
·
Received October 1, 2008
Report
- Report Number
- 1644487-2008-02186
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- January 1, 2008
- Report Date
- September 5, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
NO PROBLEMS WERE NOTED PRIOR TO RETURN OF DEVICE, BUT WAND WAS RETURNED TO MFR AND UNDERWENT PRODUCT ANALYSIS. UPON ANALYSIS, IT WAS DISCOVERED THAT THE SERIAL DATA CABLE HAD OPEN AND INTERMITTENT CONDUCTORS WHICH CAUSED COMMUNICATION ERRORS. SERIAL DATA CABLE WAS REPLACED WITH KNOWN GOOD BENCH CABLE AND ALL COMMUNICATION ERRORS CLEARED. EVERYTHING ELSE WAS OPERATING WITHIN NORMAL LIMITS AND NO VISUAL ANOMALIES WERE OBSERVED.
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 |