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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 11/06/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device showed high impedance and was disabled. Clinic notes were received indicating that the patient was experiencing an increase in seizures. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted devices have not been returned to date.

 
Manufacturer Narrative

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

 
Event Description

Analysis of the returned generator and lead was completed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Lead discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead portions. The condition of the lead suggests that patient manipulation caused the lead discontinuity. The inner silicone tubing of the negative coil has what appears to be a punctured opening. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions. Scanning electron microscopy images of the positive coil at the end of the first portion of the lead and the strand segments identified in the vicinity of the positive coil show that pitting or electro-etching conditions occurred on the coil wires.

 
Event Description

The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. The reason for explant was listed as patient self-abuse.

 
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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 Key4301752
Report Number1644487-2014-03228
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number304-20
Device LOT Number2762
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/05/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/18/2010
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: 12/05/2014 Patient Sequence Number: 1
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