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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS / LIVA NOVA USA, INC. VAGUS NERVE STIMULATOR STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

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CYBERONICS / LIVA NOVA USA, INC. VAGUS NERVE STIMULATOR STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY Back to Search Results
Model Number 101 NCP PULSE GENERATOR
Event Type  Injury  
Event Description

Was implanted with cyberonics vns. They put in a recalled device and the //ong model. It would not stop going on and very quickly caused dramatic problems. I lost use of my vocal cords for over 8 months and then partially for many years, and began having laryngo spasms many times a day. After a long time, they have finally lessened a lot but still occur. They are quite terrifying as my throat is completely closed when they happen. No air can get in or out. Also, my oxygen levels dropped and stayed low, very low, and have remained on oxygen ever since. Was a straight a student moving through a doctoral program but could not complete due to inability to think and organize logically. I was always a very joyful person, but since the implant, i fight depression every day. Sometimes very serious depression, i was always interested in everything. Since the surgery, i mostly wait to die. It's been years since the device was implanted but it has taken this long to fight my way back to enough health to know to make this complaint. I can't take legal action because within the legal time limits i was fighting for my life and could not act. One of their neurosurgeons told me later that i was never a candidate for the implant and that i was nothing more than a customer to them.

 
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Brand NameVAGUS NERVE STIMULATOR
Type of DeviceSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Manufacturer (Section D)
CYBERONICS / LIVA NOVA USA, INC.
MDR Report Key8273950
Report NumberMW5083309
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 01/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number101 NCP PULSE GENERATOR
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/23/2019 Patient Sequence Number: 1
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