FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1063657
·
Received June 20, 2008
Report
- Report Number
- 1644487-2008-01439
- Event Type
- Malfunction
- Date Received
- June 20, 2008
- Date of Event
- May 23, 2008
- Report Date
- May 23, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PHYSICIAN WAS HAVING COMMUNICATION PROBLEMS WITH A PROGRAMMING SYSTEM. HE ATTEMPTED TO RESET A VNS PATIENT'S GENERATOR TO 0MA FOR A SURGERY THE PATIENT WAS HAVING, BUT WAS UNABLE TO INTERROGATE THE DEVICE. A REPLACEMENT PROGRAMMING SYSTEM WAS SENT TO THE PHYSICIAN. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
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 |