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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 12/23/2014
Event Type  Malfunction  
Event Description

It was reported that the patient was referred for generator and lead replacement due to high impedance. X-rays were taken, but did not reveal any lead discontinuities. It is unknown if any patient manipulation or trauma occurred that may have caused or contributed to the high impedance. No known surgical interventions have been performed to date.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to lead discontinuity. The explanted devices were returned to the manufacturer for analysis. No abnormal performance or any other type of adverse condition was found with the returned pulse generator. The device performed according to functional specifications. Analysis of the returned lead confirmed discontinuity of positive quadfilar coil in the body region of the returned lead portions. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the suspected broken end of the coil. However, due to metal dissolution, a conclusive determination of the fracture mechanism of the coil cannot be made. Though it is difficult to state conclusively the most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant. The lead assembly has punctures in the outer silicone tubing and the inner tubing. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 302
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 Key4430814
Report Number1644487-2015-03663
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/25/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/19/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2009
Device MODEL Number302-20
Device LOT Number200269
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/28/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/26/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/06/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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