FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1890176
·
Received October 22, 2010
Report
- Report Number
- 1644487-2010-02393
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- August 30, 2004
- Report Date
- October 1, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY.
Description of Event or Problem · 1
DURING A REVIEW OF THE PT'S PROGRAMMING/DEVICE DIAGNOSTIC HISTORY, IT WAS FOUND THAT A FAULTED SYSTEMS DIAGNOSTICS TEST OCCURRED WHICH RESULTED IN THE PT'S DEVICE BEING DISABLED. A FINAL INTERROGATION WAS NOT PERFORMED; THEREFORE, THE SETTING CHANGE WAS NOT OBSERVED/ADDRESSED UNTIL A SUBSEQUENT OFFICE VISIT. 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 | 162256 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |