FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2211900
·
Received August 10, 2011
Report
- Report Number
- 1644487-2011-01805
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- January 21, 2009
- Report Date
- July 11, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING THE REVIEW OF THE PT'S PROGRAMMING HISTORY, IT WAS NOTED THAT A FAULTED SYSTEM DIAGNOSTIC TEST CHANGED THE PT'S PARAMETERS ON (B)(6) 2009. THE PT'S PARAMETERS WERE NOT FULLY CORRECTED UNTIL (B)(6) 2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |