FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2193125
·
Received July 22, 2011
Report
- Report Number
- 1644487-2011-01671
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- March 1, 2011
- Report Date
- July 18, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN WAS HAVING PROBLEMS WITH INTERMITTENT COMMUNICATION WITH HIS PROGRAMMING SYSTEM AND HE ATTRIBUTED THE PROBLEM TO THE PROGRAMMING WAND. HOWEVER, THE PROGRAMMING SYSTEM WAS RETURNED TO MFR FOR ANALYSIS AND DURING ANALYSIS, A PROBLEM WAS FOUND WITH THE HANDHELD COMPUTER. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD WAS UNABLE TO ESTABLISH COMMUNICATION WITH A KNOWN GOOD GENERATOR. THE CAUSE OF THE ANOMALY IS ASSOCIATED WITH A DAMAGED GROUND CONNECTION IN THE SERIAL CABLE. ONCE THE GROUND CONNECTION WAS RE-ESTABLISHED USING A JUMPER WIRE, NO FURTHER ANOMALIES WERE IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 715914 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |