FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2081411
·
Received April 22, 2011
Report
- Report Number
- 1644487-2011-00880
- Event Type
- Malfunction
- Date Received
- April 22, 2011
- Date of Event
- November 30, 2010
- Report Date
- March 23, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS UNABLE TO BE INTERROGATED. A COMPANY REPRESENTATIVE WENT TO THE SITE TO TROUBLESHOOT THE PHYSICIAN'S PROGRAMMING SYSTEM AND IT WAS FOUND THAT THE WAND BATTERY WAS DEAD WHICH MAY HAVE BEEN THE CAUSE OF THE FAILURE TO PROGRAM. HOWEVER, AS THE PATIENT WAS NO LONGER IN THE OFFICE, THE DEVICE WAS NOT ABLE TO BE RE-INTERROGATED. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 13620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |