FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3010677
·
Received March 19, 2013
Report
- Report Number
- 1644487-2013-00729
- Event Type
- Malfunction
- Date Received
- March 19, 2013
- Date of Event
- March 17, 2006
- Report Date
- February 18, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
REVIEW OF PROGRAMMING HISTORY REVEALED THAT DEVICE SETTINGS WERE AT FAULTED DIAGNOSTIC SETTINGS ON THE PATIENT'S FIRST VISIT FOLLOWING INITIAL IMPLANT SURGERY. A MANUFACTURER RECOMMENDATION IN THE DEVICE LABELING IS TO NOT PROGRAM THE DEVICE ON FOR APPROXIMATELY TWO WEEKS AFTER IMPLANTATION; HOWEVER, IT IS UNKNOWN IF THE SURGEON INTENDED FOR THE DEVICE TO BE PROGRAMMED OFF PER LABELING RECOMMENDATION. IT CANNOT BE DETERMINED IF THE SURGEON INTERROGATED THE GENERATOR PRIOR TO THE COMPLETION OF SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114358 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | MUZ | CYBERONICS INC | MODEL 250 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |