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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 10/18/2013
Event Type  Malfunction  
Event Description

Initially, it was reported that the patient was underwent generator and lead explant due to being seizure free with medication. It was reported that the patient's generator had been programmed off for about 18 months for that reason. The patient requested that the device be explanted. The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The incision mark and abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur and calcium. Abraded inner tubing openings were observed. With the exception of the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Analysis of the generator was completed on (b)(4) 2013. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

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

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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3577015
Report Number1644487-2014-00244
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/19/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2006
Device MODEL Number302-20
Device LOT Number10960
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/25/2013
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received12/19/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/20/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial