FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3221740
·
Received July 11, 2013
Report
- Report Number
- 1644487-2013-02078
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- October 22, 2009
- Report Date
- June 21, 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
DURING A REVIEW OF PROGRAMMING HISTORY ON (B)(6) 2013 IT WAS NOTED THAT ON ONE OCCASION A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED ON (B)(6) 2009. THE CHANGE IN SETTINGS WERE FOUND AND CORRECTED ON (B)(6) 2010. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320121 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | 523499 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |