• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS / LIVANOVA USA, INC. VNS; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Convulsion/Seizure (4406)
Event Date 01/02/2021
Event Type  Injury  
Event Description
Had seizure and hospitalized for 3 weeks still not being helped or treated for vns problems i am a veteran and this is who had vns implanted 1st time by u.S.Department of veterans affairs.Need help seizures have increased pain in neck chest not being treated.Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VNS
Type of Device
STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Manufacturer (Section D)
CYBERONICS / LIVANOVA USA, INC.
MDR Report Key11561940
MDR Text Key242389725
Report NumberMW5100214
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 03/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/23/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Disability;
Patient Age61 YR
Patient Weight104
-
-