FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2191316
·
Received July 27, 2011
Report
- Report Number
- 1644487-2011-01701
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- August 11, 2008
- Report Date
- July 8, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING A REVIEW OF A PT'S PROGRAMMING HISTORY AVAILABLE IN THE MFR'S PROGRAMMING HISTORY DATABASE, IT WAS FOUND THAT THE PT PRESENTED SETTINGS DIFFERENT THAN WHAT WAS INTENDED DURING AN OFFICE VISIT ON (B)(6) 2008. THE SETTINGS CHANGED AFTER SYS DIAGNOSTIC TEST ON (B)(6) 2008. NO FINAL INTERROGATION WAS PERFORMED AFTER SYS DIAGNOSTICS. ALSO, THERE WERE NO REPORTS OF ANY PT ADVERSE EVENTS AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |