FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3090458
·
Received May 2, 2013
Report
- Report Number
- 1644487-2013-01229
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- May 2, 2007
- Report Date
- April 9, 2013
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING MANUFACTURER REVIEW OF A PATIENT'S VNS PROGRAMMING HISTORY, IT WAS NOTED A FAULTED SYSTEMS DIAGNOSTICS TEST OCCURRED ON (B)(6) 2007 (DAY OF IMPLANT) WHICH CHANGED THE SETTINGS; THE OUTPUT CURRENT WAS DISABLED BUT THE MAGNET CURRENT WAS LEFT ON AT 1MA. THIS WAS NOT CORRECTED UNTIL (B)(6) 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193219 | PROGRAMMING SOFTWARE | PORGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |