FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3813071
·
Received May 15, 2014
Report
- Report Number
- 1644487-2014-01267
- Event Type
- Malfunction
- Date Received
- May 15, 2014
- Date of Event
- March 10, 2009
- Report Date
- April 21, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.
Description of Event or Problem · 1
DURING REVIEW OF PROGRAMMING AND DIAGNOSTIC HISTORY, IT WAS OBSERVED THAT AN INTERRUPTED SYSTEM DIAGNOSTIC TEST OCCURRED THAT CAUSED AN UNINTENDED CHANGE IN DEVICE SETTINGS DURING AN OFFICE VISIT ON (B)(6) 2009. THE PHYSICIAN CORRECTED THE SETTINGS; HOWEVER, THE OUTPUT CURRENT WAS NOT CORRECTED. NO PATIENT ADVERSE EVENTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290437 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | 584952 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |