FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3142993
·
Received June 3, 2013
Report
- Report Number
- 1644487-2013-01654
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 5, 2004
- Report Date
- May 7, 2013
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING A REVIEW OF THE PATIENT'S PROGRAMMING HISTORY, IT WAS FOUND THAT THE PATIENT WAS FOUND TO BE AT SETTINGS INDICATIVE OF A FAULTED TEST UPON INITIAL INTERROGATION ON (B)(6) 2004. AS NO PREVIOUS HISTORY IS KNOWN, IT IS UNKNOWN IF AND WHEN A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED WHICH WOULD HAVE ALTERED THE PATIENT'S SETTINGS. THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2004. THE SETTINGS WERE ADJUSTED AFTER THE INITIAL INTERROGATION ON (B)(6) 2004.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243069 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |