FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3152768
·
Received June 8, 2013
Report
- Report Number
- 1644487-2013-01706
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- May 5, 2010
- Report Date
- May 21, 2013
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY PERFORMED.
Description of Event or Problem · 1
REVIEW OF THE VNS PROGRAMMING HISTORY DATABASE WAS PERFORMED WHICH REVEALED THAT A FAULTED SYSTEM DIAGNOSTIC TEST CHANGED THE PATIENT¿S SETTINGS TO UNINTENDED PARAMETERS ON (B)(6) 2010. AN INTERROGATION WAS PERFORMED, AND ALL OF THE PARAMETERS WERE CORRECTED PRIOR TO THE PATIENT LEAVING THE CLINIC EXCEPT FOR THE MAGNET SIGNAL OFF-TIME. ATTEMPTS TO OBTAIN THE PATIENT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. NO PATIENT ADVERSE EVENTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254484 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |