FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 1181363
·
Received September 23, 2008
Report
- Report Number
- 1644487-2008-02245
- Event Type
- Malfunction
- Date Received
- September 23, 2008
- Date of Event
- January 1, 2008
- Report Date
- August 26, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED GROSS LEAD DISCONTINUITY. DEVICE FAILURE OCCURRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT HAD RECEIVED "ABNORMAL LEAD" DIAGNOSTIC RESULTS AND WAS EXPERIENCING AN INCREASE IN SEIZURES. X-RAYS REVIEWED BY THE MANUFACTURER REVEALED WHAT APPEARED TO BE A GROSS LEAD DISCONTINUITY AT THE CONNECTOR PIN AS WELL AS EXCESSIVE TWISTING OF THE LEAD BODY, SUGGESTING POSSIBLE PATIENT MANIPULATION, ABOVE THIS POINT. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
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 | Required Intervention |