FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2211898
·
Received August 10, 2011
Report
- Report Number
- 1644487-2011-01829
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- July 27, 2011
- Report Date
- July 11, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING REVIEW OF THE VNS PROGRAMMING HISTORY AVAILABLE TO THE MFR, IT WAS FOUND THAT AT THE FIRST DATE NOTED IN THE HISTORY THAT THE PT CAME INTO THE NEUROLOGIST'S OFFICE WITH SETTINGS INDICATIVE OF A FAULTED DIAGNOSTICS TEST. THIS DATE WAS 2 WEEKS AFTER THE IMPLANT OF THE VNS AND NO EARLIER, PROGRAMMING HISTORY IS AVAILABLE. IT IS LIKELY THAT THE FAULTED DIAGNOSTICS TEST OCCURRED DURING IMPLANT SURGERY ON (B)(6) 2006. THE SETTINGS WERE CORRECTED ON THE DATE OF DISCOVERY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE CHANGE IN SETTINGS.
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 | 20 YR |