FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1033098
·
Received April 22, 2008
Report
- Report Number
- 1644487-2008-00973
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 28, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED TO MFR THAT HIGH LEAD IMPEDANCE HAD RESULTED FROM AN UNK DIAGNOSTIC TEST PERFORMED ON THE PT'S DEVICE BY THE TREATING PHYSICIAN. ADDITIONALLY, IT WAS REPORTED THAT THE PT WAS NO LONGER SENSING NORMAL STIMULATION OF THE DEVICE. THE PT WAS REFERRED TO A SURGEON. THE PT SUBSEQUENTLY HAD SURGERY WHERE THE LEAD AND GENERATOR WERE REPLACED. ATTEMPTS TO OBTAIN ADD'L INFO FROM THE TREATING PHYSICIAN HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE. ATTEMPTS TO OBTAIN THE EXPLANTED DEVICES FOR ANALYSIS HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 1008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |