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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304-20

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CYBERONICS, INC. LEAD MODEL 304-20 Back to Search Results
Model Number 304-20
Event Date 06/01/2014
Event Type  Injury  
Event Description

During an appointment on (b)(6) 2014, the patient reported that there is a "problem with the lead" that started approximately two weeks prior. She could feel pain in ear and at the clavicle area with stimulation, but it was unclear whether it was with every stimulation on-time; however, the patient noted she could feel the stimulation on-times normally. There was no known preceding trauma, but does have a (b)(6) old and has gained weight recent. Diagnostics indicated an impedance of 2040 ohms which was within normal limits. The vns output current was lowered to 1. 25ma, which lessened the pain by the patient. Lead revision was going to be considered. Additional information was later received on 08/13/2015 indicating that the patient s device was turned off with only the magnet still on. The patient was referred for vns replacement surgery. It was noted that the patient previously wanted the device explanted, but the physician persuaded her to keep it. During system diagnostics, the patient reported pain again. No surgical intervention has occurred to date.

 
Event Description

The patient later had lead replacement surgery. Pre-operatively, lead impedance was reported to be okay. The surgeon opted to not replace the generator, as he was not sure based on her previous tolerability whether putting in another brand new generator was appropriate. The explant hospital will not return explanted products per hospital policy, so analysis is unable to be performed. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 304-20
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 Key5034354
Report Number1644487-2015-05636
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/13/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2015
Device MODEL Number304-20
Device LOT Number3204
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/30/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2012
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: 08/27/2015 Patient Sequence Number: 1
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