FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2266045
·
Received September 7, 2011
Report
- Report Number
- 1644487-2011-02111
- Event Type
- Malfunction
- Date Received
- September 7, 2011
- Date of Event
- October 5, 2010
- Report Date
- August 8, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED BY A CO PRE THAT AN INTERRUPTED SYSTEM DIAGNOSTICS TEST WAS NOTED THROUGH REVIEW OF A PT'S PROGRAMMING HISTORY LEADING TO NON-EFFICACIOUS SETTINGS. THE PT LEFT THE OFFICE PROGRAMMED TO 1MA/ 20HZ/ 500 MICROSECS/ 30 SECS/ 60 MINS DUE TO THE FAULTED DIAGNOSTICS. NO PT ADVERSE EVENTS WERE REPORTED DUE TO THE SETTING CHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 675293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |