FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3070284
·
Received April 22, 2013
Report
- Report Number
- 1644487-2013-01099
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- June 13, 2005
- Report Date
- March 24, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING REVIEW OF PROGRAMMING HISTORY IT WAS OBSERVED THAT A INCOMPLETE SYSTEMS DIAGNOSTICS OCCURRED THAT LEFT THE PATIENT PROGRAMMING TO UNINTENTIONAL SETTINGS. THERE WAS NO FINAL INTERROGATION PRIOR TO THE PATIENT LEAVING THE OFFICE AND THE SETTING CHANGED WAS NOT NOTICED AND ONLY PARTIALLY CORRECTED AT THE NEXT APPOINTMENT. THE OFF TIME WAS LEFT A 60 MINUTES OFF AND WAS NOT LOWERED UNTIL (B)(6) 2006.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172532 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |