FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3070915
·
Received April 22, 2013
Report
- Report Number
- 1644487-2013-01110
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- October 17, 2010
- Report Date
- April 1, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
WHILE PERFORMING AN INTERNAL REVIEW OF PROGRAMMING HISTORY IT WAS NOTED THAT ON (B)(6) 2010 THE DEVICE WAS INTERROGATED AND PROGRAMMED SEVERAL TIMES, A SYSTEM DIAGNOSTIC WAS PERFORMED AND RESULTED IN "FAULT", A FINAL INTERROGATION WAS PERFORMED AND THE SETTINGS WERE 1MA / 20 SF / 500 PW / 30 SECONDS ON TIME / 60 MINUTES OFF TIME WHICH ARE FAULTED DIAGNOSTIC SETTINGS. PRIOR TO THE PATIENT LEAVING THE VISIT ON (B)(6) 2010, THE DEVICE WAS NOT PROGRAMMED TO INTENDED SETTINGS. ON (B)(6) 2010 THE PATIENT'S SETTINGS WERE CORRECTED TO 1.75M A, 20 SF, 250 PW, 30 SECONDS ON TIME, 0.8 MINUTES OFF TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171898 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |