FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3021484
·
Received March 26, 2013
Report
- Report Number
- 1644487-2013-00814
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Date of Event
- April 26, 2007
- Report Date
- February 28, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE, IT WAS OBSERVED THAT A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED ON DATE OF IMPLANT, (B)(6) 2007, WHICH CHANGED THE SETTINGS TO UNINTENDED PARAMETERS. IT APPEARS THAT THE DEVICE WAS NOT INTENDED TO BE ON, BUT UPON INITIAL INTERROGATION ON (B)(6) 2007, THE OUTPUT CURRENT WAS AT 1MA. A FINAL INTERROGATION WAS NOT PERFORMED ON DATE OF IMPLANT AS RECOMMENDED IN MANUFACTURER LABELING TO IDENTIFY AND FULLY CORRECT SUCH ANOMALIES PRIOR TO PATIENTS LEAVING THE CLINIC. THE SETTINGS WERE PROGRAMMED TO INTENDED PARAMETERS ON (B)(6) 2007. NO PATIENT ADVERSE EVENTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123380 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | 521420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR |