FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 1150728
·
Received September 3, 2008
Report
- Report Number
- 1644487-2008-02080
- Event Type
- Malfunction
- Date Received
- September 3, 2008
- Date of Event
- June 19, 2008
- Report Date
- July 31, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. PRESENTATION CITATION: " EJPN SUPPLEMENT AUTHORS' MEETING- DAY 1" VNS THERAPY IN CHILDREN AND ADOLESCENTS: THE CURRENT STATE OF EVIDENCE"; 19-20 JUNE 2008.
Description of Event or Problem · 1
MANUFACTURER REVIEW OF THE CONFERENCE PRESENTATION "EJPN SUPPLEMENT AUTHORS' MEETING- DAY 1, VNS THERAPY IN CHILDREN AND ADOLESCENTS: THE CURRENT STATE OF EVIDENCE" REVEALED A VNS PATIENT HAD A LEAD FRACTURE. PER THE REPORTER, THE LEAD FRACTURE WAS IDENTIFIED VIA X-RAY OR AT LEAD REVISION SURGERY WHEN LEAD EROSION WAS NOTED. NO TRAUMA OR DEVICE MANIPULATION WAS ADMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL UNKNOWN | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |