FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1203133
·
Received October 17, 2008
Report
- Report Number
- 1644487-2008-02521
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- August 15, 2006
- Report Date
- October 15, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
RPTR INDICATED A VNS PT'S GENERATOR WAS FOUND TO BE SET TO 3.5MA OF OUTPUT CURRENT, WHICH WAS NOT THE INTENDED SETTING. THE PT WENT TO A LOCAL ER TO SEEK TREATMENT FOR PAINFUL STIMULATION IN THE NECK. THE VNS WAS REPROGRAMMED BACK TO THE INTENDED SETTINGS. PROGRAMMING HISTORY WAS OBTAINED AND ANALYZED FOR THE PT WHICH DID IDENTIFY THAT THE PT WAS INTERROGATED AND FOUND TO BE AT 3.5MA, BUT DID NOT IDENTIFY ANY ANOMALIES WHICH MAY HAVE CAUSED THE VNS OUTPUT CURRENT TO BE CHANGED TO 3.5MA. THE RPTR STATED THAT THE PT WAS NOT SEEN BY ANOTHER VNS PHYSICIAN PRIOR TO THE PATIENT BEING FOUND SET TO 3.5MA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |