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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
Event Date 05/01/2014
Event Type  Malfunction  
Event Description

The explanted lead has been returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the returned lead portion was completed and confirmed an opening of inner tubing which exposed the conductive quadfilar coils. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the exposed surface and show what appears to be wear (smoothed surfaces) at the exposed portion. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
Event Description

It was reported on (b)(6) 2015 that the patient is currently unhappy with the placement of the device. The physician referred the patient for a second opinion.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death.

 
Event Description

Initially, it was reported that the patient experienced swelling and pain over the generator site. The patient was given antibiotics and the swelling resolved. It was reported that the patient was still experiencing pain at the generator site. The patient was seen for follow-up and it was reported that there was no infection and the patient was doing better. It was later reported that the patient was being shocked by the vns and that the device was interrogated and there were no problems. It was reported that the physician thought the patient's body may not be tolerating vns. It was reported that the patient wanted the device removed. It was later reported that the patient was experiencing shocks in his jaw and left arm and that the device was programmed off and the shocking resolved. It was reported that the patient would be scheduled for surgery to explore the lead. The patient's parents want the device explanted if nothing is found to resolve this shocking. The patient underwent lead replacement due to the increased discomfort over the last three months. The surgeon believed that the lead insulation directly under one of the tie-downs was worn away. The surgeon believes that the tie-down caused damage to the lead. It was later reported that the surgeon identified a break in the lead near the vagus nerve. It was reported that the patient's symptoms have completely resolved with lead replacement. The lead is expected to be returned for analysis, but has not been received to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4128664
Report Number1644487-2014-02512
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2016
Device MODEL Number304-20
Device LOT Number3305
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/06/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/17/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/12/2012
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: 09/30/2014 Patient Sequence Number: 1
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