FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2983530
·
Received February 28, 2013
Report
- Report Number
- 1644487-2013-00544
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- May 29, 2008
- Report Date
- February 5, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
ON (B)(6) 2013 THE VNS PATIENT'S PROGRAMMING HISTORY WAS REVIEWED AND IT WAS DISCOVERED THAT ON (B)(6) 2008 A FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED THAT CHANGED THE PATIENT'S SETTINGS TO TEST SETTINGS. NO FINAL INTERROGATION WAS PERFORMED AND IT WAS NOT UNTIL THE PATIENT'S NEXT VISIT ON (B)(6) 2008 THAT THE SETTINGS WERE NOTICED AND CORRECTED. NO ADVERSE EVENTS HAVE BEEN REPORTED TO HAVE OCCURRED BECAUSE OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85652 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | 521417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |