FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2800581
·
Received October 22, 2012
Report
- Report Number
- 1644487-2012-02696
- Event Type
- Malfunction
- Date Received
- October 22, 2012
- Date of Event
- February 5, 2007
- Report Date
- September 24, 2012
- Manufacturer
- CYBERONICS
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING A REVIEW OF PROGRAMMING HISTORY FOR THIS VNS PATIENT ON (B)(6) 2012, IT WAS NOTED THAT AN INTERRUPTED DIAGNOSTIC TEST ON (B)(6) 2007 ALTERED THE PATIENT'S SETTINGS. THE PATIENT LEFT THE APPOINTMENT AT UNINTENDED SETTINGS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | MUZ | CYBERONICS | MODEL 250 | 3810731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |