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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. GENERATOR MODEL UNK

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CYBERONICS, INC. GENERATOR MODEL UNK Back to Search Results
Device Problems High impedance; Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction  
Event Description

It was reported by the physician that he had a pediatric patient who suffered nerve damage which required corrective surgery. The physician believed that high output current and rapid cycling caused heating or fibrosis which led to nerve damage. He believed that lowering output current was not effective settings for vns therapy so the physician stopped the rapid cycling with high output current. No additional relevant information has been received to date.

 
Event Description

Further follow-up with the physician found that he believed his initial report was misinterpreted. He did not believe that any of his patients suffered from nerve damage due to vns. He reported that he has had patients whose devices have been programmed to high settings and later diagnostic results indicated high impedance which the physician believed was caused by fibrosis due to the high settings. However the physician could not recall many specifics about the events and stated his report was anecdotal.

 
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Brand NameGENERATOR MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7131494
Report Number1644487-2017-05027
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/19/2017 Patient Sequence Number: 1
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