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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 12/20/2012
Event Type  Malfunction  
Event Description

Reporter indicated a patient had high lead impedance 10,000 ohms with vns diagnostics testing at an office visit. The vns was disabled. X-rays were reviewed by the manufacturer on (b)(6) 2013. No obvious lead breaks were observed. The lead pin is fully inserted into the generator header, ruling out a lead pin issue and making a lead fracture the more likely cause of the high lead impedance. The lead electrodes are situated in an unusual angle towards the general direction of where the vagus nerve is located, suggesting the electrodes may not be placed per labeling. Lead replacement surgery is planned, but has not occurred to date.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

On (b)(6) 2013, this patient underwent lead revision. The explanted lead was returned on (b)(6) 2013 and is currently undergoing product analysis.

 
Manufacturer Narrative

Serial #, lot #, expiration date: corrected data: previously submitted mdr provided incorrect lead product information. This report is being sent to correct this information. Date of implant, corrected data: previously submitted mdr provided incorrect lead product information. This report is being sent to correct this information. Device manufacture date, corrected data: previously submitted mdr provided incorrect lead product information. This report is being sent to correct this information.

 
Event Description

An analysis was performed on the returned lead portions, and the reported allegations of high impedance was confirmed. During the visual analysis of the returned portion, the (-) green electrode quadfilar coil appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed on the connector end of the (-) green electrode quadfilar coil break and identified one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical and no pitting. Scanning electron microscopy was performed on the electrode (mating) end of the (-) green electrode quadfilar coil break and identified one of the broken coil strands as being pitted and mechanically damaged. The remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. 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. 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. 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 other discontinuities were identified.

 
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 Key2916973
Report Number1644487-2013-00163
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/20/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number302-20
Device LOT Number201306
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/25/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/22/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/07/2010
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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