FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 831749
·
Received February 9, 2007
Report
- Report Number
- 1644487-2007-00016
- Event Type
- Malfunction
- Date Received
- February 9, 2007
- Date of Event
- January 1, 2006
- Report Date
- November 19, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- p970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AP AND LATERAL X-RAY VIEWS OF NECK AND CHEST EVALUATED BY MANUFACTURER. NO OBVIOUS LEAD DISCONTINUITIES NOTED. DEVICE MALFUNCTION IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT A SYSTEM DIAGNOSITCS TEST AT AN OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE, INDICATING POSSIBLE LEAD DISCONTINUITY. PATIENT UNDERWENT REVISION SURGERY AT WHICH TIME INTRA-OPERATIVE SYSTEM DIAGNOSITCS TESTING CONTINUED TO YIELD HIGH LEAD IMPEDANCE AFTER A REPLACEMENT GENERATOR WAS CONNECTED TO EXISTING LEAD. ADDITIONAL REVISON SURGERY IS LIKELY. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | LYJ | CYBERONICS, INC. | 302-20 | 010275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |