FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2950859
·
Received February 8, 2013
Report
- Report Number
- 1644487-2013-00339
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- February 27, 2008
- Report Date
- January 10, 2013
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
WHILE REVIEWING PROGRAMMING HISTORY FOR THE PATIENT IT WAS DISCOVERED THAT THE PATIENT LEFT AN APPOINTMENT AT UNINTENTIONAL SETTING DUE TO AN INCOMPLETE DIAGNOSTICS. THE PATIENT CAME INTO THE APPOINTMENT AT CORRECT SETTINGS AND INCOMPLETE DIAGNOSTICS OCCURRED DURING THE APPOINTMENT. AS A RESULT OF THE INCOMPLETE DIAGNOSTICS THE PATIENT SETTINGS WERE CHANGED. THE SETTING CHANGED WAS NOTICED DURING INTERROGATION AND PARTIALLY CORRECT BUT THE OFF TIME WAS LEFT AT 60 MINUTES. THE SETTINGS WERE NOT CORRECT UNTIL A LATER APPOINTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54506 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | 521426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |