FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3240787
·
Received July 22, 2013
Report
- Report Number
- 1644487-2013-02209
- Event Type
- Malfunction
- Date Received
- July 22, 2013
- Date of Event
- February 4, 2009
- Report Date
- June 26, 2013
- 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
ANALYSIS OF PROGRAMMING HISTORY.
Additional Manufacturer Narrative · 1
THE EVENT DATE IS UNKNOWN AND WAS INADVERTENTLY LISTED INCORRECTED ON INITIAL MFR. REPORT. THE PRODUCT INFORMATION IS NOT KNOWN AND THIS INFORMATION WAS INADVERTENTLY REPORTED ON INITIAL MFR. REPORT.
Description of Event or Problem · 1
A REVIEW OF THE PATIENT'S PROGRAMMING HISTORY FOUND THAT UPON INITIAL INTERROGATION ON (B)(6) 2009, THE PATIENT'S SETTINGS WERE SEEN TO BE DIFFERENT FROM THOSE OF THE LAST VISIT. THESE SETTINGS WERE INDICATIVE OF A FAULTED OR INCOMPLETE DIAGNOSTIC TEST; HOWEVER, NO DIAGNOSTICS WERE PERFORMED ON THAT VISIT OR THE VISIT PRIOR ((B)(6) 2006). IT IS UNKNOWN WHEN THE PATIENT'S SETTINGS WERE CHANGED AND IF OR WHEN AN INCOMPLETE DIAGNOSTIC TEST WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341257 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 584955 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |