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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 06/10/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. Pre-operative normal mode and system diagnostics revealed high impedance. When the surgeon opened the neck incision site, he observed that the lead body was in two pieces near the bifurcation. The explanted generator and lead have not been returned to date.

 
Manufacturer Narrative

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

 
Event Description

The explanted generator and lead were returned to the manufacturer for analysis. During the product analysis there were no anomalies found with the pulse generator. The generator performed according to functional specifications. Analysis of the returned lead is currently underway.

 
Manufacturer Narrative

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

 
Event Description

Analysis of the lead was completed on 08/05/2014. Scanning electron microscopy images of the broken coils and strand segments show that pitting or electro-etching conditions have occurred at the coils ends. A segment of a strand was noted at the center of coil 1. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and /or surface contamination the fracture mechanism of the coils cannot be determined. Abrasions were noted on the silicone tubing of the lead coils at approximately 0. 4-2. 8cm past the electrode bifurcation. A suspected coil break was identified at the end of both lead coils located at approximately 2. 8cm past the electrode bifurcation. The silicone tubing appears to have been torn at this location. Two strands segments became detached from the end of coil 2 during inspection of the broken end. 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 opening and the ends of the returned lead portions. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the coils. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

 
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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 Key3912686
Report Number1644487-2014-01688
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2010
Device MODEL Number302-20
Device LOT Number200520
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/07/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/05/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/07/2007
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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