FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2061854
·
Received April 4, 2011
Report
- Report Number
- 1644487-2011-00707
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- May 12, 2005
- Report Date
- March 14, 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
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING MFR REVIEW OF A PT'S VNS PROGRAMMING HISTORY, IT WAS NOTED THAT AN INTERRUPTED SYSTEMS TEST OCCURRED ON (B)(6) 2005 WHICH CAUSED THE SETTINGS TO CHANGE. THE CHANGE WAS IMMEDIATELY NOTED UPON RE-INTERROGATION AND ALL SETTINGS WERE CORRECTED EXCEPT FOR THE OFF TIME, WHICH REMAINED AT 60 MINS. THE OFF TIME WAS NOT CORRECTED UNTIL (B)(6) 2005.
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 | 17 YR |