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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
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Stroke/CVA (1770); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Increased Sensitivity (2065)
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 Name
CYBRONICS VNS FOR EPILEPSY-VAGUS NERVE STIMULATOR FOR EPILEPSY
Type of Device
CYBRONICS VNS FOR EPILEPSY-VAGUS NERVE STIMULATOR FOR EPILEPSY
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
MDR Report Key5700328
MDR Text Key46790879
Report NumberMW5062653
Device Sequence Number1
Product Code LYJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
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
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age42 YR
Patient Weight59
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