FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 4244061
·
Received November 11, 2014
Report
- Report Number
- 1644487-2014-02992
- Event Type
- Malfunction
- Date Received
- November 11, 2014
- Date of Event
- February 5, 2013
- Report Date
- October 13, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
REVIEW OF DEVICE PROGRAMMING HISTORY IDENTIFIED THAT HIGH IMPEDANCE (DC DC CODE - 7) WAS OBSERVED ON DEVICE DIAGNOSTICS. THE GENERATOR WAS PROGRAMMED OFF WHEN THE HIGH IMPEDANCE WAS OBSERVED. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2013 DUE TO A DEVICE FAILURE. THE EXPLANTED DEVICES HAVE NOT BEEN RETURNED TO DATE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727298 | LEAD MODEL UNKNOWN | LEAD | LYJ | CYBERONICS, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |