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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. CYBRONICS VNS FOR EPILEPSY-VAGUS NERVE STIMULATOR FOR EPILEPSY

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CYBERONICS, INC. CYBRONICS VNS FOR EPILEPSY-VAGUS NERVE STIMULATOR FOR EPILEPSY Back to Search Results
Model Number 105
Event Date 09/01/2010
Event Type  Injury  
Event Description

Cyberonics vns - for epilepsy patients. Two surgeries. Two separate devices, worsening, depression. Device malfunction could be fatal. First vns - implant constantly malfunctioned left scar tissue caused death/resuscitation in operating room. Caused stroke 2 times, caused permanent damage to heart/body, second device caused permanent damage and could be end by death to my life. Nerve damage, permanent sensitivity to touch, damaged nerves/pain, heart problems, scar tissue. Neuropathy could result in death. Cyberonics recently called, and they stated the surgery never should have been done. Pt id: (b)(6). Chart # at operating room: (b)(6). Surgeon: (b)(6). Surgical operating room/extended adm: (b)(6) 2015. Csn: (b)(6).

 
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Brand NameCYBRONICS VNS FOR EPILEPSY-VAGUS NERVE STIMULATOR FOR EPILEPSY
Type of DeviceCYBRONICS VNS FOR EPILEPSY-VAGUS NERVE STIMULATOR FOR EPILEPSY
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
MDR Report Key5700328
Report NumberMW5062653
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 05/14/2016
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received06/02/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number105
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/02/2016 Patient Sequence Number: 1
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