FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3132015
·
Received May 29, 2013
Report
- Report Number
- 1644487-2013-01603
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- April 29, 2004
- Report Date
- May 1, 2013
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED AN INCORRECT EVENT DATE. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES: PREVIOUSLY SUBMITTED MDR INDICATED AN INCORRECT DATA DATES.
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING REVIEW OF PROGRAMMING HISTORY IT WAS NOTED THAT THE PATIENT CAME INTO AN APPOINTMENT SET AT UNINTENTIONAL SETTINGS. IT IS SUSPECTED THAT THERE WAS AN INCOMPLETE DIAGNOSTICS AT THE PREVIOUS APPOINTMENT. THERE WAS NO FINAL INTERROGATION TO CONFIRM THE PATIENT LEFT AT THE INTENDED SETTINGS. THE PATIENT¿S SETTINGS WERE CORRECTED AT THE APPOINTMENT WHEN THE SETTING CHANGE WAS OBSERVED. THE BATTERY LIFE CALCULATION SHOWED 0.24 YEARS UNTIL NEOS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235332 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 162254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |