FDA Adverse Event
Malfunction
Summary report: N
GEN MODEL UNK
MDR report key: 2154186
·
Received June 29, 2011
Report
- Report Number
- 1644487-2011-01452
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- May 3, 2011
- Report Date
- June 3, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A VNS PROGRAMMING PHYSICIAN IN (B)(6) THAT THEY HAD SOME VNS PT'S THAT WERE HAVING COMMUNICATION ERRORS. UNK HOW MANY PTS. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENT. REPORTED: WE DO MORE OFTEN RECEIVE MESSAGES ABOUT COMMUNICATION PROBLEMS OR CHECKSUM ERROR, MAY BE MORE OFTEN WITH 103/104 MODELS, THAN WITH 102 MODELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEN MODEL UNK | LYJ | CYBERONICS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |