FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2211492
·
Received August 15, 2011
Report
- Report Number
- 1644487-2011-01868
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Date of Event
- April 15, 2009
- Report Date
- July 21, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
ON (B)(6) 2011, A VNS PATIENT'S PROGRAMMING HISTORY WAS REVIEWED. ON (B)(6) 2009 THE PATIENT PRESENTED WITH FAULTED SYSTEM DIAGNOSTIC SETTINGS OF OUTPUT=0MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=0.25MA/PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC. THE PATIENT WAS THEN PROGRAMMED TO HIGHER SETTINGS OF OUTPUT=0.25MA/FREQUENCY=20HZ/PULSE WIDTH=130USEC/ON TIME=30SEC/OFF TIME=5MIN/MAGNET OUTPUT=0.25MA/PULSE WIDTH=130USEC/MAGNET ON TIME=30SEC. NO DIAGNOSTIC TESTS WERE LISTED IN THE PATIENT'S PROGRAMMING HISTORY. (B)(4) ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE NURSE PRACTITIONER HAVE BEEN TO NO AVAIL THUS FAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | 715913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |