FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2172223
·
Received June 14, 2011
Report
- Report Number
- 1644487-2011-01343
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Report Date
- May 23, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF PROGRAMMING HISTORY CONFIRMED EVENT UNK DATE EVENT OCCURRED.
Description of Event or Problem · 1
DURING REVIEW OF INTERNAL PROGRAMMING HISTORY, IT WAS NOTED THAT AN INTERRUPTED TEST OCCURRED ON AN UNK DATE AND ANOTHER INTERRUPTED WHEN THEY WERE SEEN IN CLINIC ON (B)(6) 2010 AND UNK IF THEY LEFT THE OFFICE AT UNINTENDED THERAPY THAT DATE. THE PT CAME INTO CLINIC ON (B)(6) 2010 AND FOUND TO BE AT INTERRUPTED TEST SETTINGS 0/20/500/30/60 INSTEAD OF THEIR INTENDED THERAPY OF 1.5/30/500/30/5. ON THE SAME VISIT, AFTER INTERROGATION, ANOTHER SYSTEM TEST FAULTED AND NO INTERROGATION WAS PERFORMED. THEREFORE, UNK IF THE PT LEFT THE OFFICE AT UNINTENDED THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |