FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3205194
·
Received July 3, 2013
Report
- Report Number
- 1644487-2013-02036
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- August 27, 2009
- Report Date
- June 11, 2013
- Manufacturer
- CYBERONICS
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 VNS GENERATOR PROGRAMMING HISTORY A FAULTED SYSTEM DIAGNOSTICS WERE NOTED. THE PATIENT WAS AT SETTINGS OUTPUT CURRENT= 1.25 MA/ FREQUENCY= 30 HZ/ PULSE WIDTH= 500 USEC/ON TIME= 30 SEC/OFF TIME= 5 MIN / MAGNET OUTPUT CURRENT= 0 MA/ PULSE WIDTH= 500 USEC / ON TIME= 60 SEC. A FAULTED DIAGNOSTICS OCCURRED WHICH CHANGED THE PATIENT¿S SETTINGS TO OUTPUT CURRENT= 0 MA/ FREQUENCY= 20 HZ/ PULSE WIDTH= 500 USEC/ON TIME= 30 SEC/OFF TIME= 60 MIN / MAGNET OUTPUT CURRENT= 1 MA/ PULSE WIDTH= 500 USEC / ON TIME= 30 SEC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305279 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | MUZ | CYBERONICS | MODEL 250 | 523507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |