FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3042648
·
Received April 9, 2013
Report
- Report Number
- 1644487-2013-00958
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Date of Event
- March 7, 2007
- Report Date
- March 13, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING REVIEW OF THE PATIENT'S PROGRAMMING HISTORY ON (B)(6) 2013 IT WAS OBSERVED THAT A FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED THAT CHANGED THE PATIENT'S SETTINGS ON (B)(6) 2007. THE PATIENT WAS REPROGRAMMED AFTERWARDS BUT ONLY THE ON TIME WAS FIXED. NO ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED DUE TO THIS SETTINGS CHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145223 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |