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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

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CYBERONICS STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Dyspnea (1816)
Event Type  Injury  
Event Description
It was reported that the patient experienced difficulty breathing and became non-verbal when a magnet was placed over their chest.When the magnet was placed over the patient's chest again, they became responsive again.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Type of Device
STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Manufacturer (Section D)
CYBERONICS
MDR Report Key17531707
MDR Text Key321090176
Report NumberMW5138620
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 12/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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