FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1172154
·
Received September 11, 2008
Report
- Report Number
- 1644487-2008-02195
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 12, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER THAT THE PHYSICIAN WAS EXPERIENCING ISSUES WITH THE PROGRAMMING SYSTEM WHEN INTERROGATING THE PATIENT'S DEVICE. THE HANDHELD HAD TO BE RESET SEVERAL TIMES AND THERE WERE LONG DELAYS IN RECEIVING THE INTERROGATION RESULTS. A NEW HANDHELD WAS SENT TO THE SITE, PER PHYSICIAN'S REQUEST, AS A REPLACEMENT FOR THE OLD HANDHELD TO HELP RESOLVE THE ISSUE. THE PROGRAMMING WAND IS SUSPECTED TO BE THE PROBLEM COMPONENT IN THE SYSTEM AS THE EVENT IS LIKELY DUE TO A COMMUNICATION ISSUE. GOOD FAITH ATTEMPTS TO CONFIRM THAT THE ISSUE RESOLVED AFTER REPLACING THE HANDHELD ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING WAND | LYJ | CYBERONICS, INC. | 201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |