FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3191599
·
Received June 26, 2013
Report
- Report Number
- 1644487-2013-01937
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- April 21, 2011
- Report Date
- June 4, 2013
- Manufacturer
- CYBERONICS
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING REVIEW OF PROGRAMMING HISTORY FOR THE PATIENT IT WAS OBSERVED THAT THE PATIENT¿S SETTINGS WERE CHANGED AS A RESULT OF AN INCOMPLETE DIAGNOSTICS. THERE WAS NO FINIAL INTERROGATION AND THE PATIENT LEFT THE APPOINTMENT AT UNINTENTIONAL SETTINGS. THE SETTINGS WERE CORRECTED AT A LATER APPOINTMENT. ANOTHER INCOMPLETE DIAGNOSTICS OCCURRED AGAIN ON THE DATE THAT THE SETTINGS WERE FULLY CORRECTED. THERE WAS NO FINAL INTERROGATION. THE PATIENT CAME IN TO THE NEXT APPOINTMENT SET TO UNINTENTIONAL SETTINGS. THE UNINTENTIONAL SETTINGS WERE NOTICED BUT THE SETTINGS WERE NEVER FULLY CORRECTED AND THE PATIENT WAS STILL AT 60 MINUTES OFF ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290678 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | MUZ | CYBERONICS | MODEL 250 | 842377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |