FDA Adverse Event
Injury
Summary report: N
PROGRAMMING WAND
MDR report key: 1697875
·
Received May 12, 2010
Report
- Report Number
- 1644487-2010-01131
- Event Type
- Injury
- Date Received
- May 12, 2010
- Date of Event
- April 12, 2010
- Report Date
- April 12, 2010
- Manufacturer
- CYBERONICS INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
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 PROGRAMMING WAND WAS NOT COMMUNICATING WITH A PT'S VNS GENERATOR DESPITE CHANGING THE WAND BATTERY. ATTEMPTS FOR FURTHER INFO FROM THE REPORTER ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING WAND | PROGRAMMING WAND | LYJ | CYBERONICS INC. | 201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |