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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 01/26/2015
Event Type  Malfunction  
Event Description

High impedance was observed during diagnostics tests performed around (b)(6) 2015. Patient also experienced increased seizure at that time. Patient underwent lead replacement on (b)(6) 2015 and the explanted lead was returned on (b)(6) 2015. During surgery, fibrosis was observed and was surgically removed in order for the new lead to be placed. Additional information was received that the high impedance was first noted on (b)(6) 2015 initially when the physician performed normal mode diagnostic test after increasing the output current to 0. 75 ma. The results indicated dcdc=7 and high lead impedance. Lead pin insertions issue was tested and was ruled out as the issue. Good diagnostics and normal impedance was observed for this patient after implant prior to high impedance. Patient's seizures was reported to have increased since (b)(6) 2015. The relation to pre-vns baseline is unknown at this time. Patient manipulation or trauma is not believed to have contributed to the high impedance. Analysis of the lead is underway but has not been completed.

 
Event Description

An analysis was performed on the returned lead portions. A portion of the lead was not returned to the manufacturer and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the lead, the quadfilar coil appeared to be broken at the proximal end of the anchor tether. Analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. An abraded opening was found on the outer silicone tubing. No other obvious anomalies were noted.

 
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)
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 Key4596345
Report Number1644487-2015-04121
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2017
Device MODEL Number302-20
Device LOT Number202399
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/02/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/08/2013
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: 03/12/2015 Patient Sequence Number: 1
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