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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. VAGUS NERVE STIMULATOR (VNS); STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

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LIVANOVA USA, INC. VAGUS NERVE STIMULATOR (VNS); STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY Back to Search Results
Patient Problem Convulsion/Seizure (4406)
Event Type  Injury  
Event Description
The caller was a patient with a vagus nerve stimulator (vns).The caller requested magnets for their vns, noting that they had a seizure but could not find any magnets, which was "almost death" for them.Agent reviewed that the vns is not a mdt device and redirected the caller to livanova for further assistance.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
VAGUS NERVE STIMULATOR (VNS)
Type of Device
STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Manufacturer (Section D)
LIVANOVA USA, INC.
MDR Report Key18913773
MDR Text Key337917754
Report NumberMW5152891
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 03/13/2024
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? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/14/2024
Patient Sequence Number1
Treatment
STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION).
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