FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2170972
·
Received June 30, 2011
Report
- Report Number
- 1644487-2011-01460
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 6, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
FOLLOWING A GENERATOR'S EXPLANT, IT WAS RECEIVED FOR PRODUCT ANALYSIS AT SETTINGS INDICATIVE OF A FAULTED DIAGNOSTIC TEST. THE LAST KNOWN SETTINGS FROM THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE WERE FROM (B)(6) 2007, AND THEY WERE AS INTENDED FOR THE PATIENT'S THERAPY AT THAT TIME. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
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 |