FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2972674
·
Received February 21, 2013
Report
- Report Number
- 1644487-2013-00474
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- November 28, 2007
- Report Date
- January 22, 2013
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED PAINFUL STIMULATION WHEN THE PHYSICIAN RAN A SYSTEMS DIAGNOSTICS TEST AND HE ABORTED THE TEST. THE PATIENT REPORTED HE CONTINUED TO HAVE PAINFUL STIMULATION AFTER HE LEFT THE APPOINTMENT. REVIEW OF THE PROGRAMMING HISTORY FOR THE PATIENT REVEALED THAT THE SYSTEM DIAGNOSTICS THAT WAS RUN LEAD TO THE PATIENT TO HAVE THEIR SETTING CHANGED AS IT WAS NO ABLE TO COMPLETE. THERE WAS NO FINAL INTERROGATION AND THE PATIENT LEFT THE APPOINTMENT AT UNINTENTIONAL SETTINGS WHICH LED TO THE PAINFUL STIMULATION THAT HE EXPERIENCED AFTER THE APPOINTMENT. THE PATIENT RETURNED AT A LATER APPOINTMENT AND THE SETTINGS WERE CORRECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76201 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | 536290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |