FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1081943
·
Received July 23, 2008
Report
- Report Number
- 1644487-2008-01691
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 26, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT COMMUNICATION COULD NOT BE ESTABLISHED WITH A TEST GENERATOR WHEN USING A SITE'S PROGRAMMING WAND. WHEN ANOTHER HANDHELD COMPUTER WAS ATTACHED TO THE WAND, COMMUNICATION STILL COULD NOT BE ESTABLISHED INDICATING THAT THE WAND WAS A LIKELY SOURCE OF THE PROBLEM. THE WAND BATTERIES WERE CHANGED, CONNECTIONS WERE CHECKED, AND THERE WAS NOT BELIEVED TO BE ANY EMI. THE WAND HAS BEEN RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS, AND A NEW WAND HAS BEEN SENT TO THE SITE.
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 |