FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1041185
·
Received May 9, 2008
Report
- Report Number
- 1644487-2008-01113
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 10, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT HER VNS THERAPY PROGRAMMING WAND WAS NOT OPERATING PROPERLY, IN THAT IT WOULD NOT COMMUNICATE WITH PTS' PULSE GENERATORS. WAND IN QUESTION WAS SUBSEQUENTLY RETURNED TO MFR FOR PRODUCT ANALYSIS, HOWEVER, THAT ANALYSIS IS NOT YET COMPLETE.
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 |