FDA Adverse Event Other Summary report: N

VAGUS NERVE STIMULATOR

MDR report key: 2822876 · Received November 2, 2012

Report

Report Number
MW5027486
Event Type
Other
Date Received
November 2, 2012
Date of Event
September 1, 2000
Manufacturer
CYBERONICS, INC.
Product Code
LYJ
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 1994, I WAS DIAGNOSED WITH SEVERE DEPRESSION. FOR FIVE YEARS, I MUST HAVE TRIED TEN DIFFERENT MEDICATIONS AND FOUR OR FIVE LOCAL PSYCHIATRISTS. I BECOME PART OF A MEDICAL STUDY HE WAS DIRECTING FOR CYBERONICS, INC. TO STUDY THE VAGUS NERVE STIMULATOR. IN 2010 OR 2011, AT ONE OF MY VISITS WITH DR (B)(6) AT (B)(6), HIS COMPUTER DISCOVERED "HIGH IMPEDANCE" WITHIN MY DEVICE. WE TOOK X-RAYS, SENT THEM TO CYBERONICS FOR REVIEW, AND LATER LEARNED THAT THERE WAS A PROBLEM WITH THE LEAD; THE DEVICE WOULD HAVE TO BE REPAIRED. MOREOVER, AFTER MEETING WITH THE NEUROSURGEON AT (B)(6), I LEARNED THAT HE WOULD NEED TO REPLACE THE ENTIRE VNS SYSTEM. DURING A HOSPITAL STAY IN (B)(6) 2011, THE DEVICE WAS TURNED OFF. DR (B)(6) AND A NEURO-PSYCHIATRIST, DR (B)(6) AT (B)(6), HAVE BOTH STRONGLY ADVISED ME OF THE NEED FOR THIS SURGERY. THEY STRESS THAT, WITHOUT THE DEVICE, THEY ARE AFRAID THAT I WOULD GRADUALLY REVERT TO MY ORIGINAL DEPRESSED STATE. THEY ALSO STRESSED THE IMPORTANT NEED TO REDUCE OR STOP SOME OF MY NUMEROUS MEDICATIONS. DR (B)(6) DISCOVERED THE IMPEDANCE. THEREFORE, MY DEVICE WAS TURNED OFF OVER A YEAR AGO AND HAD NOT BEEN WORKING FOR SOME TIME BEFORE THAT. ACCORDING TO THE DOCTORS MENTIONED ABOVE, THE DEVICE NEEDS TO BE REMOVED AND REPLACED. RECENTLY I DISCOVERED THAT THE REPLACEMENT SURGERY WILL COST FROM (B)(6), AND THE COST WOULD BE MY RESPONSIBILITY. I DO NOT UNDERSTAND WHY CYBERONICS REQUIRES ME TO PAY FOR THIS MALFUNCTION OF THEIR DEVICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VAGUS NERVE STIMULATOR NONE LYJ CYBERONICS, INC.

Patients

Seq Age Sex Outcome Treatment
1