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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 09/10/2014
Event Type  Malfunction  
Event Description

The explanted generator and lead were received for analysis. The returned product form indicated that generator and lead replacement was performed due to lead discontinuity. Analysis of the generator was completed on 01/21/2015. 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. Analysis of the lead was completed on 01/23/2015. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 81mm portion an abraded opening was observed on inner silicone tubing 1 approximately 9mm-10mm from the end of the electrode bifurcation and quadfilar coil 1 appeared to be exposed. The surface of quadfilar coil 1 appeared to be pitted in this area. Scanning electron microscopy was performed on the quadfilar coil surface and identified the area as having extensive pitting. With the exception of the abraded inner tubing opening and coil pitting, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. 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, and no discontinuities were identified.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, 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) 2014. The explanted devices have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was reported that device diagnostics resulted in high impedance. It was reported that the patient had recently undergone generator replacement surgery on (b)(6) 2014. The patient was going to be scheduled for surgery, but the patient's mother wants to wait. No surgical intervention has been performed to date. No relevant information has been received to date.

 
Manufacturer Narrative

Device failure is suspected, 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 Key4162117
Report Number1644487-2014-02618
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2014
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 Manufacturer01/09/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/09/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/11/2007
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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