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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 04/11/2014
Event Type  Malfunction  
Event Description

The generator appears in the left abdominal area in an abnormal placement.

 
Manufacturer Narrative

The initial manufacturer report incorrectly stated that the x-rays showed normal placement of the generator in the upper left chest. The x-rays showed abnormal placement of the generator in the left abdominal area.

 
Event Description

It was reported that the vns patient¿s device was tested on (b)(6) 2014 and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently programmed off. There was no change in the patient¿s seizure activity. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin was fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the x-rays images, the cause high lead impedance could not be determined. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. During the procedure, it was noted that the electrode had visible damage right beyond the anchor tether. The explanting facility discarded the explanted products; therefore, no analysis can be performed.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Device manufacturing records and available programming and diagnostic history were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure occurred, but did not cause or contribute to 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 Key3796059
Report Number1644487-2014-01200
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/07/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2006
Device MODEL Number302-20
Device LOT Number010904
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/13/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/09/2004
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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