FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 4061664
·
Received September 4, 2014
Report
- Report Number
- 1644487-2014-02234
- Event Type
- Malfunction
- Date Received
- September 4, 2014
- Date of Event
- June 5, 2002
- Report Date
- August 8, 2014
- 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
RELEVANT TESTS/LABORATORY DATA, CORRECTED DATA: THE INITIAL MANUFACTURER REPORT INADVERTENTLY PROVIDED AN INCORRECT DATE FOR THE FAULTED SYSTEM DIAGNOSTIC TEST.
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
ON (B)(6) 2014 DURING A REVIEW OF PROGRAMMING HISTORY, IT WAS OBSERVED THAT A SYSTEM DIAGNOSTIC TEST OCCURRED ON (B)(6) 2002 WHICH RESULTED IN A SETTINGS CHANGE. ALL SETTINGS WERE NOT CORRECTED PRIOR TO THE PATIENT LEAVING THE OFFICE VISIT; THE MAGNET OUTPUT WAS INADVERTENTLY LEFT AT THE INCORRECT SETTINGS OF OUTPUT=1MA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 542200 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |