FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2081505
·
Received April 19, 2011
Report
- Report Number
- 1644487-2011-00842
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 21, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED BUT DID CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S VNS SHOWED HIGH LEAD IMPEDANCE AND NEEDED TO HAVE HIS VNS REPLACED. X-RAYS HAD BEEN TAKEN THAT DID NOT SHOW ANY LEAD DISCONTINUITIES AS PER THE PHYSICIAN, HOWEVER, THESE X-RAYS WERE NOT SENT TO THE MANUFACTURER FOR REVIEW. SURGERY TO REPLACE THE PATIENT'S LEAD AND GENERATOR HAS OCCURRED. FOLLOW-UP WITH THE NEUROLOGIST DETERMINED THAT NO TRAUMA OR MANIPULATION HAD BEEN REPORTED. THE EXPLANTED GENERATOR AND LEAD WILL REPORTEDLY BE RETURNED, HOWEVER, THEY HAVE NOT BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 010220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |