FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3173740
·
Received June 17, 2013
Report
- Report Number
- 1644487-2013-01809
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- June 29, 2010
- Report Date
- May 21, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
A REVIEW OF THE PATIENT'S PROGRAMMING HISTORY FOUND THAT A FAULTED SYSTEM DIAGNOSTIC TEST WAS PERFORMED ON (B)(6) 2010. A FINAL INTERROGATION WAS NOT PERFORMED AFTER THIS TEST; HOWEVER, UPON INITIAL INTERROGATION AT THE FOLLOWING OFFICE VISIT, ON (B)(6) 2010, THE SETTINGS WERE FOUND TO BE DIFFERENT AND INDICATIVE OF THE FAULTED TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274052 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | 521396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |