FDA Adverse Event
Injury
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2870271
·
Received December 12, 2012
Report
- Report Number
- 1644487-2012-03297
- Event Type
- Injury
- Date Received
- December 12, 2012
- Date of Event
- May 23, 2008
- Report Date
- December 7, 2012
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RELEVANT TESTS/LABORATORY DATA, CORRECTED DATA: INITIAL MDR INADVERTENTLY LISTED THE WRONG DATE FOR THE FINAL PROGRAMMING.
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
ON (B)(6) 2012 DURING REVIEW OF THE VNS PATIENT'S PROGRAMMING HISTORY, IT WAS DISCOVERED THAT ON (B)(6) 2008, A GENERATOR DIAGNOSTIC TEST WAS PERFORMED, WHICH CHANGED THE PATIENT'S SETTINGS. IT WAS NOT UNTIL (B)(6) 2009, THAT THESE INCORRECT SETTINGS WERE OBSERVED AND THE PATIENT WAS RE-PROGRAMMED TO THE INTENDED SETTINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | MUZ | CYBERONICS, INC. | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other| R |