FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1052248
·
Received May 23, 2008
Report
- Report Number
- 1644487-2008-01207
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION 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 PROPERLY COMMUNICATING WITH PT'S PULSE GENERATORS. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. WAND WAS SUBSEQUENTLY RETURNED TO MFR FOR 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 |