FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2980852
·
Received February 27, 2013
Report
- Report Number
- 1644487-2013-00532
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 23, 2007
- Report Date
- February 4, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
ON (B)(6) 2007, AN INTERRUPTED SYSTEM DIAGNOSTIC TEST OCCURRED THAT ALTERED GENERATOR SETTINGS. THE SETTINGS WERE NOT RETURNED TO EFFICACIOUS VALUES PRIOR TO THE PATIENT LEAVING THE OFFICE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85689 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | 521408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |