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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 09/23/2012
Event Type  Malfunction  
Event Description

Reporter indicated that during a vns generator replacement surgery, high lead impedance was noted with the resident lead and new generator. The patient received a new lead and generator. As a lead pin issue was ruled out, a lead fracture is the more likely cause of the high impedance. Attempts for additional information are in progress. The explanted vns generator and lead were returned. Analysis of the generator did not reveal any anomalies, and the generator performed per specifications. The generator was at end of service. Review of internal programming data from the generator indicated an impedance change from normal to high impedance occurred on (b)(6) 2012. Analysis of the lead is pending.

 
Event Description

All attempts to the reporter for additional information have been unsuccessful to date. Analysis of the vns lead was completed. During the visual analysis of the returned 39mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 1mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area on one of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on three of the quadfilar coil strands was identified as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem 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. 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 and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional 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 other discontinuities were identified. Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

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

 
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2955092
Report Number1644487-2013-00358
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/11/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2008
Device MODEL Number302-20
Device LOT Number1036
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/12/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/13/2005
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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