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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/16/2015
Event Type  Injury  
Event Description

It was reported that a patient was experiencing painful stimulation. At the patient's request, the neurologist referred the patient to a surgeon for lead revision surgery; however, the functionality of the lead is unclear. No additional relevant information has been provided to date. No surgical intervention has occurred to date.

 
Event Description

The neurologist reported that the patient's painful stimulation began around 1. 5 years prior to the report. The patient reportedly felt the pain in her neck and all the way up into her ear. The neurologist did not believe the painful stimulation was caused by a lead fracture. The lead revision surgery that was planned as intervention for the painful stimulation was for patient comfort at the time of referral. Diagnostic test results from the date that the painful stimulation began were within the normal limits. No additional relevant information has been provided to date. No known surgical intervention has occurred to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key6546060
Report Number1644487-2017-03720
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/29/2018
Device MODEL Number304-20
Device LOT Number203152
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/06/2014
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: 05/04/2017 Patient Sequence Number: 1
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