FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2994203
·
Received March 8, 2013
Report
- Report Number
- 1644487-2013-00646
- Event Type
- Malfunction
- Date Received
- March 8, 2013
- Date of Event
- December 16, 2005
- Report Date
- March 4, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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 AVAILABLE IN THE MANUFACTURER'S DATABASE, IT WAS OBSERVED THAT A FAULTED SYSTEM DIAGNOSTIC TEST ON (B)(6) 2005 AND WAS NOT CORRECTED UNTIL (B)(6) 2006. A FINAL INTERROGATION WAS NOT PERFORMED PRIOR TO THE PATIENT LEAVING THE CLINIC. THEREFORE, THE PROGRAMMING ANOMALY WAS NOT IDENTIFIED UNTIL (B)(6) 2006. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100048 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | 366970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |