FDA Adverse Event
Injury
Summary report: N
LEAD MODEL 302
MDR report key: 1104302
·
Received August 8, 2008
Report
- Report Number
- 1644487-2008-01836
- Event Type
- Injury
- Date Received
- August 8, 2008
- Date of Event
- October 30, 2007
- Report Date
- July 11, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ARTICLE REFERENCE: PHYSIOLOGY & BEHAVIOR, 94, (2008), 136-153; DE-STABILIZATION OF THE POSITIVE VAGO-VAGAL REFLEX IN BULIMIA NERVOSA. FARIS, PL, ET AL.
Description of Event or Problem · 1
REPORTER INDICATED DURING MFR REVIEW OF PUBLISHED LITERATURE ARTICLE TITLED "DE-STABILIZATION OF THE POSITIVE VAGO-VAGAL REFLEX IN BULIMIA NERVOSA" THAT FOR ONE VNS PT IT WAS NOTED DURING EXPLANT OF THE VNS THERAPY SYSTEM THAT THE LEAD ELECTRODES HAD MIGRATED. ATTEMPTS FOR FURTHER INFO FROM THE REPORTER ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | BULIMIA NERVOSA (UNAPPROVED) | LYJ | CYBERONICS, INC. | 302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |