FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2810191
·
Received October 31, 2012
Report
- Report Number
- 1644487-2012-02794
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- July 9, 2012
- Report Date
- October 2, 2012
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF PROGRAMMING HISTORY.
Additional Manufacturer Narrative · 1
PRODUCT ANALYSIS REVIEW.
Description of Event or Problem · 1
PRODUCT ANALYSIS FOR THIS GENERATOR WAS APPROVED ON (B)(6) 2012. PA RESULTS INDICATED THAT THE DEVICE WAS RETURNED AT SETTINGS INDICATIVE OF A FAULTED SYSTEM DIAGNOSTIC TEST. IT IS UNKNOWN WHEN THE EVENT OCCURRED.
Description of Event or Problem · 1
ADDITIONAL PROGRAMMING HISTORY WAS REVIEWED ON (B)(6) 2013 SHOWING NO RECENT OR INTERRUPTED DIAGNOSTICS. THE EVENT LIKELY OCCURRED ON THE DATE OF EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |