FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1023675
·
Received April 1, 2008
Report
- Report Number
- 1644487-2008-00830
- Event Type
- Malfunction
- Date Received
- April 1, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 3, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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
REPORTER INDICATED THAT A PT WENT TO THE PHYSICIAN'S OFFICE BECAUSE HE COULD NO LONGER FEEL VNS STIMULATION. AT THE OFFICE VISIT, IT WAS FOUND THAT BOTH SYSTEM AND NORMAL MODE DIAGNOSTIC TESTS SHOWED HIGH LEAD IMPEDANCE. IT IS BELIEVED BY THE PHYSICIAN'S OFFICE THAT THE PT COULD NO LONGER FEEL STIMULATION DUE TO THE HIGH LEAD IMPEDANCE. IT WAS REPORTED THAT NO TRAUMA OR MANIPULATION OF THE DEVICE HAD OCCURRED. ATTEMPTS FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE. REVISION SURGERY IS LIKELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 929 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |