FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2061818
·
Received March 30, 2011
Report
- Report Number
- 1644487-2011-00669
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- June 12, 2006
- Report Date
- February 28, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
WHILE REVIEWING THE PROGRAMMING HISTORY AVAILABLE TO THE MFR, IT WAS FOUND THAT SETTINGS INDICATIVE OF A FAULTED DIAGNOSTICS TEST WERE PRESENT AT THE INITIAL INTERROGATION OF THE PT'S VNS ON (B)(6) 2006. ALTHOUGH THE CURRENT WAS RE-PROGRAMMED LATER THAT VISIT, THE OFF TIME WAS NOT CHANGED UNTIL (B)(6) 2006. NO ADVERSE EVENTS AS A RESULTS OF THE ANOMALY HAVE BEEN REPORTED.
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 | 20 YR |