FDA Adverse Event
Injury
Summary report: N
GENERATOR
MDR report key: 1040261
·
Received May 7, 2008
Report
- Report Number
- 1644487-2008-01099
- Event Type
- Injury
- Date Received
- May 7, 2008
- Date of Event
- April 7, 2008
- Report Date
- April 7, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS PT "HAS LOST OVER 40 LBS AND SHE WAS THIN AT TIME OF IMPLANT. THE VNS GENERATOR IS 'RUBBING' AND MIGRATING UP TO THE SKIN, WEARING THE SKIN AND SURGEON FEELS WILL WORK ITS WAY THRU." THE PT REPORTEDLY HAS GOOD CONTROL OF HER SEIZURES. THE GENERATOR IS CAUSING THE PT PAIN AT THE GENERATOR SITE. THE PT UNDERWENT SURGERY TO REPOSITION AND THEN RE-STITCHED THE GENERATOR. DIAGNOSTIC TESTING BEFORE AND AFTER THE SURGERY WERE WITHIN NORMAL LIMITS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENERATOR | LYJ | CYBERONICS, INC. | 102 | 015852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |