FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2181258
·
Received July 8, 2011
Report
- Report Number
- 1644487-2011-01530
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- July 28, 2010
- Report Date
- June 13, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
METHOD: MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: REVIEW OF X-RAYS BY THE MFR REVEALED A GROSS LEAD FRACTURE. CONCLUSIONS: DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED TO OUR COUNTRY REP IN THE (B)(4) THAT THERE WAS A VNS PT WITH HIGH LEAD IMPEDANCE ON THEIR SYSTEM DIAGNOSTIC TESTING. X-RAYS WERE REVIEWED AT THE MFR AND A GROSS LEAD BREAK WAS NOTED NEAR THEIR ELECTRODES. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 1530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Female |