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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: (LIVANOVA USA, INC. / CYBERONICS) SENTIVA VNS STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

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(LIVANOVA USA, INC. / CYBERONICS) SENTIVA VNS STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY Back to Search Results
Model Number 1000
Event Date 10/18/2018
Event Type  Death  
Event Description

Reporter states her son had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours as his rhythm was stop and go. He was pronounced dead at 11am. A few weeks prior to this event, the pt had an mri done, in which his vns was turned off and the on again by a different neurologist. After the exam, the vns would constantly turn on and off on its own and started to affect his vocal cords. Her son mention he believed the neurologist may have turned the vns up too high and he wanted to have it explanted. She reports the device wasn't helping him and his seizures were getting worse, increasing to 6 violent episodes a month. She also notes her son was agitated and had horrible heartburn the day before he died which literally "knocked him forward. " the autopsy came back negative for any abnormal tests.

 
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Brand NameSENTIVA VNS
Type of DeviceSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Manufacturer (Section D)
(LIVANOVA USA, INC. / CYBERONICS)
MDR Report Key8155362
Report NumberMW5082061
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Report Date 12/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number1000
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
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: 12/11/2018 Patient Sequence Number: 1
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