FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNK
MDR report key: 1172181
·
Received September 11, 2008
Report
- Report Number
- 1644487-2008-02220
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- January 1, 1998
- Report Date
- August 14, 2008
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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. MURPHY JV, HORNING GW, SCHALLERT GS, TILTON CL, ADVERSE EVENTS IN CHILDREN RECEIVING INTERMITTENT LEFT VAGAL NERVE STIMULATION. PEDIATR NEUROL 1998;19(JULY):42-4.
Description of Event or Problem · 1
IN REVIEW OF AN ARTICLE, IT WAS REPORTED THAT A VNS PT EXPERIENCED A LEAD FRACTURE NOT ASSOCIATED WITH ANY KNOWN TRAUMA. THE FRACTURE WAS DISCOVERED ON AN X-RAY WHEN THE DEVICE STARTED TO FAIL. THE LEAD WAS REVISED UNDER GENERAL ANESTHESIA WITHOUT ADVERSITY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL UNK | LYJ | CYBERONICS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |