FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1181597
·
Received September 25, 2008
Report
- Report Number
- 1644487-2008-02300
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 27, 2008
- Report Date
- August 27, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY INTERROGATING THE PT'S DEVICE DURING A ROUTINE PROGRAMMING SESSION. THE PHYSICIAN PERFORMED TROUBLESHOOTING AND WAS UNABLE TO RESOLVE THE ISSUE. THE SITE HAS HAD SIMILAR PROBLEMS IN THE PAST WHEN THEY USED THE SAME WAND WITH DIFFERENT HANDHELD DEVICES ON VARIOUS PTS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO AND PRODUCT FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING WAND | NONE | LYJ | CYBERONICS, INC. | 201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |