FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1071714
·
Received July 9, 2008
Report
- Report Number
- 1644487-2008-01569
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- May 1, 2008
- Report Date
- June 9, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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
IT WAS REPORTED THAT DIAGNOSTIC TESTING RESULTED IN HIGH LEAD IMPEDANCE AT A ROUTINE OFFICE VISIT. NO PT MANIPULATION OR TRAUMA WAS REPORTED THAT COULD HAVE CONTRIBUTED TO THE HIGH LEAD IMPEDANCE. FULL REVISION SURGERY WAS PERFORMED. GOOD FAITH ATTEMPTS TO OBTAIN THE EXPLANTED PRODUCT FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |