FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1062994
·
Received June 18, 2008
Report
- Report Number
- 1644487-2008-01414
- Event Type
- Malfunction
- Date Received
- June 18, 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
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THE PATIENT WAS SEEN AND HAD A SYSTEMS DIAGNOSTIC TEST THAT RESULTS IN HIGH LEAD IMPEDANCE ERI NO. X-RAYS WERE TAKEN AND ARE GOING TO BE SENT TO MANUFACTURER FOR REVIEW. THE PATIENT'S VNS WAS PROGRAMMED TO ZERO OUTPUT CURRENT. THE PATIENT HAD REPORTED NOT FEELING STIMULATION AND DID NOT HAVE A HISTORY OF FALLS, TRAUMA, OR REPETITIVE MOTIONS. IT HAS BEEN DECIDED TO SEE HOW THE PATIENT DOES WITHOUT VNS THERAPY BEFORE A DECISION IS MADE ON THEIR CONTINUED VNS THERAPY AND REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 1528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |