FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3800130
·
Received May 8, 2014
Report
- Report Number
- 1644487-2014-01220
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Date of Event
- March 12, 2012
- Report Date
- April 10, 2014
- 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.
Description of Event or Problem · 1
DURING REVIEW OF THE PROGRAMMING/DIAGNOSTIC HISTORY DATABASE, IT WAS OBSERVED THAT DURING AN OFFICE VISIT ON (B)(6) 2012 THE PATIENT¿S SETTINGS WERE DIFFERENT THAN WHAT WERE PROGRAMMED AT THE SAME VISIT. THE SETTINGS FOUND WERE INDICATIVE OF A FAULTED DIAGNOSTIC TEST WHICH OCCURRED ON (B)(6) 2012. THE PHYSICIAN CORRECTED THE SETTINGS; HOWEVER, THE MAGNET ON TIME WAS NOT CORRECTED. NO PATIENT ADVERSE EVENTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278823 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | 841226 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |