FDA Adverse Event Malfunction Summary report: N

VNS DEMIPULSE

MDR report key: 2000421 · Received May 22, 2010

Report

Report Number
2000421
Event Type
Malfunction
Date Received
May 22, 2010
Date of Event
April 20, 2010
Report Date
May 19, 2010
Manufacturer
CYBERONICS, INC.
Product Code
LYJ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

PATIENT HAS INTRACTABLE EPILEPSY AND AN OLIGODENDROGLIOMA IN THE FRONTAL LOBE. APPROXIMATELY 10 OR 11 MONTHS AGO, A VAGUS NERVE STIMULATOR (VNS) WAS PLACED INTO POSITION FOR HER BECAUSE HER SEIZURES HAVE BEEN POORLY CONTROLLED WITH MEDICAL THERAPY. AT THE TIME OF SURGERY, THE IMPEDANCE TEST OF THE ELECTRODE YIELDED A SOMEWHAT HIGH IMPEDANCE OF 45. AT THE TIME THE SYSTEM WAS INSPECTED VERY CAREFULLY BECAUSE THIS VALUE WAS SOMEWHAT UNUSUAL, AND DID NOT NOTICE ANY EXCESSIVE TISSUE AFFECTING THE NERVE. AFTER DISCUSSIONS WITH CYBERONICS AT THE TIME, THEY RECOMMENDED TO CONTINUE WITH THE IMPLANTATION PROCESS, AS THE IMPEDANCE WAS BELOW THE MAXIMUM THRESHOLD ALLOWED. PATIENT DID APPEAR TO HAVE A RESPONSE FROM THE DEVICE. HOWEVER, A WHILE AFTER IMPLANTATION THE IMPEDANCE ROSE FROM VALUES THAT HAD INITIALLY BEEN POSTOPERATIVELY IN THE 7000 RANGE TO GREATER THAN 100,000. SUBSEQUENTLY, LATER ON LAST YEAR, THE LEAD IMPEDANCE WAS HIGH ENOUGH THAT THE DEVICE INDICATED IT WAS NOT TRANSMITTING CURRENT PROPERLY. DESPITE THIS, PATIENT HAS HAD WHAT HER FAMILY DESCRIBES AS A RESPONSE TO THE DEVICE. IT IS, HOWEVER, NOT ENTIRELY CLEAR THAT IS WORKING FOR HER, AND IN ADDITION, THE POTENTIAL FAILURE OF THE DEVICE HAS MADE IT VERY DIFFICULT TO OBTAIN A MRI FOR HER. SPECIFICALLY, THERE IS A CONCERN THAT THE ELECTRODE LEAD IS BROKEN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VNS DEMIPULSE STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY LYJ CYBERONICS, INC. 103 N/A

Patients

Seq Age Sex Outcome Treatment
1 19 YR