FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1980012
·
Received January 24, 2011
Report
- Report Number
- 1644487-2011-00109
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- February 20, 2006
- Report Date
- December 28, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD: REVIEW OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY.
Description of Event or Problem · 1
DURING A REVIEW OF THE PT'S PROGRAMMING HISTORY, IT WAS FOUND THAT A FAULTED SYSTEMS DIAGNOSTIC TEST OCCURRED IN 2006 WHICH RESULTED IN THE PT'S DEVICE BEING PROGRAMMED OFF FOR APPROX 3 MONTHS. A FINAL INTERROGATION WAS NOT PERFORMED AT THE END OF THE OFFICE VISIT TO ENSURE THE PT'S SETTINGS WERE AS INTENDED. THE PT'S SETTINGS WERE CORRECTED AT A F/U VISIT IN (B)(6) 2006. 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. | MODEL 250 | 521410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |