FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2081396
·
Received April 22, 2011
Report
- Report Number
- 1644487-2011-00846
- Event Type
- Malfunction
- Date Received
- April 22, 2011
- Date of Event
- March 23, 2011
- Report Date
- March 24, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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
A VNS PHYSICIAN REPORTED THAT HE SAW A VNS PT AND SYSTEM DIAGNOSTICS REVEALED HIGH IMPEDANCE. X-RAYS WERE PERFORMED AND THE PHYSICIAN STATED HE COULD VISUALIZE A FRACTURE IN THE WIRE. THE PHYSICIAN STATED HE DID NOT HAVE ANY REASON FOR THE CAUSE OF THE FRACTURE, BUT THE PT WAS REPORTED TO BE NON-VERBAL AND BANGS HIS HEAD ON OBJECTS. THE PT WAS TO BE REFERRED FOR A FULL REVISION. THE X-RAY FILMS HAVE NOT BEEN SENT TO THE MFR TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 200936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |