FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2180838
·
Received July 7, 2011
Report
- Report Number
- 1644487-2011-01514
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- November 14, 2003
- Report Date
- June 14, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
ON (B)(6), 2011, A VNS TREATING PHYSICIAN PROVIDED PROGRAMMING HISTORY FOR A VNS PT. REVIEW OF THE PT'S PROGRAMMING HISTORY REVEALED THAT A SYSTEM DIAGNOSTIC TEST WAS INTERRUPTED ON (B)(6), 2011, THE PT'S IMPLANT DATE, WHICH INADVERTENTLY CHANGED THE PT'S SETTINGS TO SYSTEM DIAGNOSTIC TEST PARAMETERS. NO FINAL INTERROGATION WAS PERFORMED AND IT WASN'T UNTIL THE PT'S FOLLOWING APPOINTMENT ON (B)(6), 2003 THAT THE SETTINGS IN QUESTION WERE FOUND AND CORRECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |