FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2170975
·
Received June 30, 2011
Report
- Report Number
- 1644487-2011-01477
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- August 28, 2009
- Report Date
- June 3, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DIAGNOSTIC DATA CONFIRMS THAT A LEAD TEST WAS INTERRUPTED ON (B)(6) 2009, WHICH INADVERTENTLY CHANGED THE PT'S SETTINGS TO UNINTENDED SETTINGS AND NO FINAL INTERROGATION WAS PERFORMED ON THIS VISIT. ON (B)(6) 2009, THE SETTINGS IN QUESTION WERE FOUND AND CORRECTED.
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 | 12 YR |