FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1061901
·
Received June 16, 2008
Report
- Report Number
- 1644487-2008-01392
- Event Type
- Malfunction
- Date Received
- June 16, 2008
- Date of Event
- April 21, 2008
- Report Date
- May 19, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 A VNS WAND WAS NOT INTERROGATING PTS. THE WAND BATTERY WAS CHANGED AND THE WAND WAS ABLE TO INTERROGATE SOME PTS BUT NOT ALL. THE WAND HAS BEEN REQUESTED FOR RETURN. A NEW WAND WAS SENT TO THE SITE AND THE REPORTER INDICATED THERE WERE NO MORE PROBLEMS INTERROGATING PATIENTS WITH THE NEW WAND.
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 |